BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G-JET® TRANSGASTRIC-JEJUNAL FEEDING DEVICE

    MDR report key: 14345277 · Received May 10, 2022

    Report

    Report Number
    14345277
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    March 21, 2022
    Report Date
    May 6, 2022
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS BEING TURNED FOR A DIAPER CHANGE AND GASTROJEJUNOSTOMY (GJ) WAS NOTED TO BE SITTING ABOUT 1 INCH OUT OF ABDOMEN. PATIENT REQUIRED A KUB AND SURGICAL REPLACEMENT OF GJ TUBE. BALLOON RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804318 G-JET® TRANSGASTRIC-JEJUNAL FEEDING DEVICE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. GJ-1430-45 200827189

    Patients

    Seq Age Sex Outcome Treatment
    1 4745 DA Male