BD D015251MK - Intraosseous Manual Driver Needle Set Kit, 15G x 25 mm, 6/CS (Continental US Only) (Temporarily Unavailable for Sale)
The BD D015251MK Needle Set Kit is a manual intraosseous vascular access device designed for use by trained healthcare professionals when rapid vascular access is required and conventional intravenous access is difficult, delayed, or unsuccessful. The kit features a 15-gauge intraosseous needle with a 25 mm length and uses a manual insertion technique rather than a powered driver.
Intraosseous access provides a temporary route to the vascular system through the medullary space of an appropriate bone. When correctly placed and clinically verified, the access route may support administration of compatible emergency medications, fluids, and other prescribed therapies according to institutional protocols and current clinical guidance.
The 25 mm needle length provides an intermediate-depth option for appropriately selected patients and anatomical insertion sites. Proper needle-length selection is essential and should be based on patient anatomy, tissue depth over the selected insertion site, clinical circumstances, and current manufacturer instructions.
The manual-driver design relies on controlled clinician-applied pressure and rotational technique rather than an electrically powered intraosseous driver. This configuration may be relevant in emergency and critical-care environments where a manual intraosseous access method is included in institutional protocols.
BD D015251MK is commercially listed as six kits per case. Availability should be confirmed before ordering because the product has been associated with a lot-specific manufacturer recall and is currently listed by CIA Medical as temporarily unavailable for sale.
Key Benefits
- 15-gauge intraosseous needle designed for emergency vascular-access procedures.
- 25 mm needle length provides an intermediate-depth option for appropriately selected patients and insertion sites.
- Manual insertion configuration does not require an electrically powered driver.
- Supports rapid vascular-access workflows when conventional peripheral IV access is difficult or delayed.
- Provides an alternative emergency access route for compatible medications and fluids when clinically indicated.
- Manual technique may support preparedness in environments where powered intraosseous equipment is unavailable or not preferred.
- Designed for use by appropriately trained emergency, trauma, and critical-care professionals.
- Part of a broader intraosseous needle range offering different lengths for varying patient anatomy and tissue depth.
- Individual device packaging supports procedural readiness and controlled inventory handling.
- Six-per-case commercial packaging supports institutional stocking when current availability and regulatory status permit.
Compatibility and Applications
The BD D015251MK is intended for manual intraosseous vascular-access procedures performed by appropriately trained healthcare professionals using current manufacturer instructions and established institutional protocols.
Potential clinical environments include emergency departments, trauma centers, intensive care units, resuscitation areas, emergency medical services, operating environments, military medicine, disaster-response programs, and other settings where rapid vascular access may be necessary.
Intraosseous access may be considered when peripheral intravenous access cannot be established rapidly enough for urgent therapy. Once correct placement has been confirmed, the intraosseous route may support administration of compatible medications, fluids, and other therapies permitted by clinical protocol.
The 25 mm needle length should be selected only after assessing tissue depth, anatomical insertion site, patient size, and other relevant clinical factors. Inadequate needle length may prevent appropriate penetration into the intraosseous space, while inappropriate length selection may affect placement and stability.
The D015251MK manual configuration should not be confused with D015251NK, which is the corresponding 25 mm needle kit configuration intended for a powered intraosseous driver.
Compatibility with connectors, extension components, securement devices, infusion equipment, and other vascular-access accessories should be confirmed according to current manufacturer instructions before use.
Usage Guidelines
The BD D015251MK should be used only by healthcare professionals trained and authorized to perform intraosseous vascular-access procedures. Current manufacturer instructions, institutional protocols, aseptic technique, and applicable emergency-care guidelines should be followed throughout the procedure.
- Confirm the clinical indication for intraosseous access before beginning the procedure.
- Assess the patient for contraindications according to current clinical and manufacturer guidance.
- Select an approved anatomical insertion site appropriate for the patient and clinical situation.
- Assess tissue depth carefully before selecting the 25 mm needle configuration.
- Verify the exact BD D015251MK catalog number before use.
- Check the lot number against current BD recall and corrective-action information.
- Inspect the package and device for damage, contamination, or compromised integrity.
- Prepare the selected insertion site using appropriate antiseptic technique.
- Position and stabilize the selected extremity or anatomical site according to clinical protocol.
- Use the approved manual insertion technique described in current manufacturer instructions.
- Apply controlled pressure and rotation without excessive or uncontrolled force.
- Confirm appropriate intraosseous placement before administering prescribed therapy.
- Remove the stylet according to current manufacturer instructions and sharps-safety procedures.
- Connect compatible extension and infusion components using aseptic technique.
- Secure the intraosseous access device to reduce movement or accidental dislodgement.
- Monitor the insertion site continuously for swelling, leakage, infiltration, extravasation, displacement, or other complications.
- Follow institutional guidance regarding the permitted duration of intraosseous access.
- Transition to another appropriate form of vascular access when clinically feasible.
- Remove the device according to current manufacturer and institutional procedures.
- Dispose of used needles and sharps immediately in an approved sharps container.
Stop use and reassess the access site if appropriate placement cannot be confirmed, unexpected resistance occurs, infusion does not proceed as expected, or swelling, leakage, significant pain, displacement, or another abnormality develops.
Certifications and Safety Standards
The BD D015251MK is intended for professional medical use within established emergency vascular-access, infection-prevention, occupational safety, and sharps-management programs.
Healthcare facilities should maintain procedures addressing patient assessment, insertion-site selection, correct needle-length selection, manual insertion technique, aseptic preparation, intraosseous placement confirmation, securement, infusion management, complication monitoring, device removal, and sharps disposal.
BD D015251MK was included in a voluntary manufacturer recall involving specified intraosseous product lots. Reported issues included increased force required to separate the stylet from the intraosseous needle and potential failure of the stylet safety mechanism to deploy after placement.
Difficulty removing the stylet could potentially result in inadvertent removal of the entire needle assembly or inability to remove the stylet from an indwelling intraosseous needle, resulting in loss of functional access and possible treatment delay.
Failure of the stylet safety mechanism to deploy may increase the risk of accidental needlestick exposure. Appropriate sharps precautions should therefore be followed throughout insertion, stylet removal, handling, and disposal.
Healthcare organizations should review current manufacturer and regulatory documentation for applicable FDA status, UDI information, affected recall lots, corrective actions, storage requirements, expiration information, warnings, precautions, contraindications, and other product-specific safety requirements.
Comparison with Competitors
Compared with powered intraosseous access systems, the BD D015251MK uses a manual insertion technique. This eliminates dependence on an electrically powered driver but requires appropriate clinician training and controlled manual technique for cortical bone penetration.
Compared with BD D015251NK, the D015251MK is the manual-driver version of the 25 mm intraosseous needle configuration. The NK configuration is intended for powered-driver insertion, while the MK configuration is specifically designed for manual use.
Compared with a 15 mm intraosseous needle, the 25 mm configuration provides additional insertion length for patients or anatomical sites with greater tissue depth.
Compared with longer 35 mm, 45 mm, or 55 mm intraosseous needle options, the 25 mm configuration provides a shorter access profile for patients who do not require the additional length of those configurations.
Compared with conventional peripheral IV cannulation, intraosseous access provides an alternative route when rapid intravenous access is difficult or unsuccessful during urgent clinical situations.
Compared with central venous catheter placement, intraosseous access may provide a faster temporary emergency vascular-access option but is not intended to replace appropriate longer-term vascular access when such access can be safely established.
Alternative intraosseous systems may vary in insertion method, needle gauge, available needle lengths, safety mechanisms, stabilization design, training requirements, and accessory compatibility. Product selection should consider patient anatomy, institutional protocols, staff competency, equipment availability, and current regulatory status.
Typical User Profile and Application Scenarios
The BD D015251MK is intended for healthcare professionals trained in manual intraosseous vascular-access procedures. Typical users may include emergency physicians, emergency nurses, paramedics, trauma clinicians, critical-care professionals, anesthesiology personnel, advanced practice clinicians, and other appropriately qualified healthcare providers.
Common use environments include emergency departments, intensive care units, trauma centers, ambulances, emergency medical service programs, resuscitation areas, operating environments, military medical services, and disaster-response settings.
The device may be considered when urgent vascular access is required and conventional peripheral intravenous access is difficult, delayed, or unsuccessful.
The 25 mm configuration may be selected when patient anatomy and tissue depth require more insertion length than a shorter 15 mm needle but do not require one of the longer available intraosseous needle configurations.
Potential clinical scenarios include emergency medication administration, rapid fluid therapy, resuscitation, trauma management, and other urgent situations where appropriately established intraosseous vascular access is clinically indicated.
Best Practices for Use and Maintenance
BD D015251MK is a procedural intraosseous access product. Best practices focus on inventory control, recall verification, correct needle-length selection, clinician competency, aseptic technique, placement confirmation, site monitoring, and safe sharps disposal.
- Verify the exact catalog number D015251MK during purchasing, receiving, and inventory management.
- Check all existing inventory by lot number against current BD recall and corrective-action information before release for clinical use.
- Do not use affected recalled inventory unless current manufacturer instructions specifically permit its use following an approved corrective process.
- Store unopened products according to current manufacturer recommendations.
- Protect packaging from moisture, excessive temperature, crushing, punctures, and contamination.
- Maintain staff competency in manual intraosseous insertion techniques.
- Confirm that the 25 mm needle length is appropriate for the selected patient and anatomical insertion site.
- Use strict aseptic technique throughout preparation, insertion, connection, and access management.
- Apply controlled manual pressure and rotation according to manufacturer instructions.
- Confirm successful intraosseous placement before administering prescribed therapy.
- Use caution during stylet removal and confirm appropriate sharps-safety handling.
- Secure the access device appropriately after successful placement.
- Monitor continuously for infiltration, extravasation, swelling, leakage, displacement, or neurovascular compromise.
- Follow current institutional and manufacturer guidance regarding duration of intraosseous access.
- Transition to appropriate alternative vascular access when clinically feasible.
- Dispose of used needles, stylets, and other sharps immediately in an approved sharps container.
- Document the insertion site, device size, time of placement, therapies administered, monitoring findings, and removal according to institutional procedures.
Regulatory and Safety Information
BD D015251MK is identified by BD as a Manual Driver Needle Kit with a 25 mm x 15-gauge intraosseous needle configuration. It should be used only by appropriately trained healthcare professionals in accordance with current manufacturer labeling, institutional protocols, and professional clinical judgment.
This catalog number was included in BD's June 2022 voluntary recall of specified intraosseous needle set kits, manual driver kits, and powered drivers. The recall was subsequently classified by the FDA as a Class I medical device recall.
The identified concerns included difficulty separating the stylet from the intraosseous needle and potential failure of the stylet safety mechanism to deploy. These issues could result in loss of intraosseous access, delays in treatment, or accidental needlestick exposure.
The recall was lot-specific rather than a statement that every D015251MK manufactured at all times was affected. Facilities with existing inventory should verify both the catalog number and lot number against the most current BD recall information before clinical use.
The FDA recall database currently lists the associated recall as open and classified. Procurement and clinical teams should therefore verify current manufacturer disposition instructions, corrective actions, availability, and regulatory status before purchasing, distributing, or using this product.
Incorrect needle-length selection, improper manual insertion, unsuccessful stylet removal, device displacement, or inadequate monitoring may contribute to failed vascular access, extravasation, tissue injury, compartment syndrome, infection, fracture, treatment delay, or other complications.
The 25 mm needle should be selected only after appropriate assessment of patient anatomy, tissue depth, anatomical insertion site, clinical indication, and current manufacturer guidance.
BD identifies one device per individual package in its product recall documentation. CIA Medical commercially lists BD D015251MK as six kits per case and currently identifies the product as temporarily unavailable for sale. Current availability and ordering eligibility should be confirmed before purchase.
How to Order
Select the BD D015251MK - Needle Set Kit, 25mm, Manual and add it to your cart when available. Complete checkout with your preferred shipping and payment options. For bulk orders, quotes, availability confirmation, or further assistance, contact CIA Medical customer service at (312)275-5850 or use the contact form on this page.
