Entuit Gastrostomy Balloon Retention Feeding Tube is used to provide gastric access for enteral feeding, medication administration, and decompression through an established gastrointestinal stoma tract. The feeding tube is a sterile device consisting of a silicone balloon, bi-lumen shaft, three-port funnel and bolster that allows for proper retention during enteral feeding, medication administration and decompression. The device contains one valve that allows for inflation and deflation of the silicone balloon.

Intended Use/Indications For Use: The feeding tube is intended to provide gastric access for enteral feeding, medication administration and decompression through an established gastrointestinal stoma tract. The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract.

Contraindications: Device placement is contraindicated for patients with evidence of granulation tissue, infection, and/or irritation in the stoma site.

Precautions: This device should only be used for its intended purpose by or under the supervision of trained healthcare professionals with a comprehensive understanding in clinical principles, procedures and risks associated with percutaneous placement of enteral feeding devices. It is recommended to adhere to the instructions for use provided with this device, the enteral feeding instructions for the healthcare facility and instructions recommended by physicians.

Device Preparation

Warning: An inappropriately sized tube may cause leakage of gastric contents, necrosis, granulation
tissue, sepsis, associated sequelae and/or buried bumper syndrome.

• Select the appropriately sized feeding tube based on the diameter of patient’s stoma.
• Inspect package integrity before use. Do not use device if package is damaged or if the sterile barrier has been compromised.
• Remove device from package and inspect contents for damage. Do not use contents if damaged.
• Slide external bolster up and down shaft several times to ensure bolster can be adjusted to properly secure device when placed.
• Inflate the feeding tube balloon to recommended fill volume (printed on the device) with sterile or distilled water using a sterile syringe. Caution: Only use sterile or distilled water for balloon inflation. Do not use air, saline, feeding formula, medication, or radiopaque contrast for balloon inflation. Inflate balloon slowly to prevent buildup of excess pressure in inflation system.
• Verify balloon integrity by visually inspecting inflated balloon for symmetry and by gently squeezing the balloon to determine if the balloon is leaking. Balloon symmetry may be improved by gently manipulating the inflated balloon up and down. Do not use device if any suspected characteristics that may affect the performance of the balloon are noted.
• Deflate balloon by reinserting syringe and removing all water from balloon. Do not attempt to use device if balloon cannot be deflated.
• If necessary, lubricate the tip of the device with a water soluble lubricant for ease of insertion. Sterile gauze pads may be used for ease of tip lubrication. Note: Do not use petroleum jelly or mineral oil for tip lubrication.

Handling And Storage: Store in a cool, dry, and secure environment to prevent damage.

Product selection note:

• Order the Entuit Feeding Tube with the ENFit Connection if your facility has ENFit-compatible giving sets and syringes.
• Order the Entuit Feeding Tube without the ENFit Connection if your facility is using giving sets and syringes with a luer lock connection.