Cook Medical G07361 - C-FMT-8.0-70, EACH

Cook Medical G07361 - C-FMT-8.0-70, EACH

Frederick-Miller Feeding Tube Set

The Frederick-Miller Enteral Feeding Tube is an 8.5 French enteral feeding tube.

Features and Benefits

• The weighted distal end facilitates the passage of the tube.
• The wire guide allows placement of the tube under fluoroscopic control.
• The three sideports in the distal portion of the catheter are designed to facilitate feeding.
• The tube comes with an attached enteral feeding adapter.

Components

• 8 Fr Radiopaque Polyvinylchloride Catheter
• Straight PTFE Coated Stainless Steel Wire Guide
• Multipurpose Tubing Adapter

Intended Use

The Frederick-Miller Enteral Feeding Tube is intended for enteral feeding.

Contraindications

Use of the Frederick-Miller Enteral Feeding Tube is contraindicated in patients with the following conditions:

• Esophageal varices
• Gastric varices
• INR (international normalized ratio) > 1.3 (at time of insertion and/or expected at time of removal)
• Anticoagulated patients (anticoagulated at time of insertion and/or expected to be anticoagulated at time of removal)
• Pathologic coagulopathies
• History of bleeding disorder(s)
• Small or large bowel obstruction(s)
• Ischemic bowel
• Peritonitis
• Esophageal stricture or obstruction
• Gastric obstruction
• Recent nasal, oral, esophageal, or gastric surgery or trauma
• Deviated septum
• Inability to pass the feeding tube through the nares
• Uncooperative patient

Precautions

• The product is intended for use by physicians trained and experienced in placement of small bowel feeding tubes. Standard techniques for placement of small bowel feeding tubes should be employed.
• Do not use a syringe smaller than 30 mL when irrigating tube.
• When removing the Frederick-Miller Enteral Feeding Tube through the nose or mouth, proceed very slowly.
• This product contains DEHP (di(2-ethylhexyl)phthalate).
• The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects.

Potential Adverse Events

Potential adverse events associated with placement and use of a FrederickMiller Enteral Feeding Tube include, but are not limited to:

• Bleeding
• Clogged or leaking feeding tube
• Sinusitis
• Premature displacement of the tube
• Aspiration
• Nasal irritation
• Sore throat

Instructions for Use

• Place the patient in a supine position on the fluoroscopic table.
• Advance the wire guide into the feeding tube to within 5 cm of the tube tip.
• Advance the tube through the nares into the oropharynx.
• If patient can swallow, place a few drops of water in the mouth and advance the tube as the larynx elevates during swallowing.
• In the absence of voluntary or reflex swallowing, advance the tube under fluoroscopic control into the esophagus. Inadvertent entry into the tracheobronchial tree can be recognized fluoroscopically and corrected.
• The tube may be advanced from the esophagus into the gastric fundus and usually will loop and pass without difficulty into the antrum.
• Advance the wire guide to the tip of the tube during this time to provide increased rigidity; occasionally, a curved, stiff wire guide end, advanced into the distal end of the feeding tube, may be necessary to direct the tube from the fundus into the antrum.
• Once at the pylorus, advance the tube over the wire guide or with the wire guide into the duodenum.

Post-Placement Care

If using a Luer tip syringe for flushing purposes, remove feeding adapter and connect Luer converter to the hub of the jejunal catheter. Remove Luer converter and connect the feeding adapter after flushing the catheter.

How Supplied

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).