Description

The MIC-KEY Low Profile Balloon Gastrostomy Feeding Tube, developed by Avanos Medical, Inc., is a specialized medical device designed for patients requiring long-term enteral nutrition and medication delivery. Its low-profile design ensures discretion and comfort, sitting at skin level to minimize the risk of snagging or accidental removal. This makes it an unobtrusive option for daily use.

Key Features

• Balloon Retention Mechanism: The tube is anchored securely by an internal, inflatable silicone balloon, reducing the risk of dislodgement. The balloon's fill volume varies by tube size, typically ranging from 3 to 10 ml.

• Material: Constructed from medical-grade silicone, the tube is latex-free, ensuring compatibility with a wide range of patients.

• Feeding Port: Equipped with an anti-reflux valve to prevent leakage of stomach contents when not in use.

• ENFit Connectors: These connectors ensure safe, standardized enteral connections and are compatible with ENFit extension sets, helping to prevent misconnections.

• Radiopaque Stripe: A stripe is included for imaging and placement verification, enhancing the accuracy of the tube's positioning.

Size and Configuration Options

The tube is available in various French diameters, such as 12 Fr, 16 Fr, 20 Fr, 22 Fr, and 24 Fr, with different stoma lengths to accommodate individual patient anatomy. It offers gastric (G), gastro-jejunal (GJ), and jejunal (J) configurations. GJ tubes provide separate ports for simultaneous feeding and decompression, while J tubes feature a tapered distal tip and anti-reflux valve.

Intended Use and Environment

This device is suitable for pediatric, teen, and adult patients and can be placed using various methods, including percutaneous, endoscopic, laparoscopic, fluoroscopic techniques, or through an established stoma tract. It is intended for use in hospital, home, and community health settings.

Kit Contents

The kit may include:

• MIC-KEY Low-Profile Gastrostomy Feeding Tube with ENFit connectors
• 12-inch continuous feed extension set (ENFit)
• 12-inch bolus feed extension set (ENFit)
• 6 ml luer slip syringe
• 35 ml ENFit enteral feeding syringe
• Insertion stylet (US only)
• Water-soluble lubricant (US only)
• Gauze pad
• Patient use & care guide

Maintenance and Care

General maintenance involves daily cleaning of the tube and stoma site with mild soap and water, regular flushing of extension sets, and monitoring balloon volume. It is crucial to use only MIC-KEY extension sets with MIC-KEY tubes and to perform tube and stoma length assessments with a clinician if needed.

Cautions

Users should verify package integrity before use, avoid reusing or resterilizing the device, and ensure the correct extension set is used. Monitoring for potential issues such as leakage, blockage, or tube dislodgement is essential, along with protecting the device from excessive force and certain oils that may degrade the tube. Medications should be administered in liquid form to prevent clogging.