BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G-JET® TRANSGASTRIC-JEJUNAL FEEDING DEVICE

    MDR report key: 16408135 · Received February 21, 2023

    Report

    Report Number
    16408135
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    October 22, 2022
    Report Date
    February 13, 2023
    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'S GASTROJEJUNOSTOMY (GJ) TUBE WAS DISLODGED BY ABOUT 3CM WITH THE BALLOON JUST AT THE SKIN SITE. THE BALLOON WAS DEFLATED AND HAD FAILED AS IT WAS NOT ABLE TO BE RE-INFLATED. NASOGASTRIC (NG) TUBE WAS PLACED FOR TEMPORARY FEEDING AND MEDICATION ACCESS. GJ TUBE EXCHANGED UNDER FLUOROSCOPY WITH GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943238 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