Description

The 16Fr MIC Bolus Balloon Gastrostomy Tube by Avanos is a specialized medical device designed for patients requiring long-term enteral feeding. It serves those who cannot tolerate oral feeding and is suitable for both adult and pediatric patients at low risk for aspiration. This versatile tube can also be used for gastric decompression and direct medication delivery into the stomach.

Key Features

• Low-Profile Design: The tube's low-profile design facilitates bolus feeding and venting, offering discretion and comfort.
• Medical-Grade Silicone: Constructed from medical-grade silicone, Tritan, and barium sulphate, ensuring durability and biocompatibility.
• Radiopaque Stripe: Includes a radiopaque stripe for enhanced visibility under imaging, aiding in accurate placement.

Secure Placement

The device features an inflatable internal retention balloon, with a recommended fill volume of 5 ml, and a SECUR-LOK external retention ring to ensure secure placement. The tapered and recessed distal tip enhances comfort and safety.

Compatibility and Safety

• ENFit Connectors: Equipped with ENFit connectors, including a male ENFit feeding port, to prevent misconnections.
• Anti-Reflux Valve: The feeding port includes an anti-reflux valve that opens upon attachment of the extension set.
• MR Safe: The tube is MR safe or MR conditional and free from natural rubber latex, DEHP, DBP, and BBP.

Sterilization and Packaging

The tube is a sterile, single-use device, primarily sterilized using gamma radiation. It is individually packaged in a Tyvek pouch, ensuring hygiene and integrity. The device is CE marked (Class IIb, BSI 2797) and manufactured in compliance with ISO13485 standards in Mexico.

Kit Contents

The kit may include various components such as:

• Gastrostomy tube with balloon valve
• Extension set port cover
• 6 ml Luer slip syringe
• 35 ml enteral feeding syringe with ENFit connector
• Continuous and bolus feed extension sets
• Gauze pads and water-soluble lubricant

Maintenance and Care

Proper care involves daily cleaning of the tube and stoma site with mild soap and water. The tube should be rotated 360° plus a quarter turn to prevent sticking. Replacement of the tube and extension sets should follow clinical guidance.

Contraindications and Complications

Contraindications include conditions such as ascites, colonic interposition, and portal hypertension. Potential complications may involve skin breakdown, infection, and pressure necrosis, necessitating careful monitoring and management.

Storage

Store the device in a cool, dry place, and ensure it is not reused, reprocessed, or resterilized. The shelf life extends to 3 years from the date of manufacture, provided the packaging remains undamaged.