BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS

    MDR report key: 21691324 · Received March 25, 2025

    Report

    Report Number
    MW5168197
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 19, 2025
    Manufacturer
    AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025, THIS PATIENT HAD A GASTROSTOMY TUBE PLACED IN THE OPERATING ROOM WITH ORDERS FOR GTUBE TO GRAVITY DRAINAGE. IN SETTING UP THE TUBE TO GRAVITY DRAINAGE, THE NURSE SELECTED THE INCORRECT BAG. THE BAG THAT WAS USED WAS A NEPHROSTOMY BAG PRODUCT URESIL REF TC600. THIS BAG WAS INCORRECTLY ATTACHED TO THE GTUBE BALLOON PORT AND RESULTED IN THE DEFLATION OF THE BALLOON AND RESULTED IN THE DISLODGEMENT OF THE TUBE. ON (B)(6) 2025, THE PATIENT RETURNED TO THE OPERATING ROOM TO HAVE THE GTUBE REPLACED. ALTHOUGH THERE IS NO DEVICE ERROR, THAT CONTRIBUTED TO HARM, IT WAS NOTED IN THE REVIEW OF THE EVENT THAT THERE IS NO VISUAL INDICATOR OR COLOR CODING FOR THE FEEDING PORTS OR THE BALLOON PORTS. REPORTING TO MAKE THE RECOMMENDATION FOR VISUAL INDICATOR TO DIFFERENTIATE THESE PORTS. MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS 18 F REF 8100-18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415910 AVANOS MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female Other