BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G-JET TRANSGASTRIC-JEJUNAL FEEDING DEVICE

    MDR report key: 14626125 · Received June 7, 2022

    Report

    Report Number
    1526012-2022-00009
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    April 1, 2022
    Report Date
    June 7, 2022
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071101824
    PMA / PMN Number
    K123716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A RESPONSE TO UF REPORT # (B)(4) WHICH WAS RECEIVED BY AMT FROM THE FDA ON 05/11/2022. BASED ON THE PROVIDED INFORMATION, THE COMPLAINT IS NOT A REPORTABLE EVENT PER 21 CFR SECTION 803. THERE WAS NO DEATH. THERE WAS NO SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. AMT CONFIRMED WITH THE DEVICE REFERENCED IN THE REPORT IS NOT AVAILABLE FOR RETURN. SINCE THE DEVICE WAS NOT RETURNED, A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED AND DEVICE FAILURE CANNOT BE CONFIRMED AT THIS TIME. A DEVICE HISTORY REVIEW WAS COMPLETED FOR THE REPORTED LOT NUMBER AND NO ANOMALIES WERE FOUND AND THERE HAVE BEEN NO OTHER COMPLAINT REPORTS FROM OTHER USERS FOR THIS SAME BATCH. THE COMPLAINT INFORMATION HAS BEEN LOGGED INTO OUR COMPLAINT DATABASE FOR TRENDING PURPOSES. COMPLAINT # (B)(4) WAS ASSIGNED TO THIS REPORT.

    Description of Event or Problem · 0

    PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #: (B)(4), "DESCRIBE THE EVENT OR PROBLEM: G-JET TUBE BALLOON RUPTURED CAUSING THE TUBE TO BE LOOSE. THE TUBE REMAINS IN THE POST-PYLORIC POSITION. THE TUBE WAS SECURE TO THE ABDOMINAL WALL WITH TAPE. TUBE ULTIMATELY REQUIRED REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254285 G-JET TRANSGASTRIC-JEJUNAL FEEDING DEVICE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. GJ-1430-45 200827-189 00842071101824

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male