BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G-JET® TRANSGASTRIC-JEJUNAL FEEDING DEVICE

    MDR report key: 10013255 · Received April 30, 2020

    Report

    Report Number
    10013255
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 20, 2020
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    APPLIED MEDICAL TECHNOLOGIES G-JEY BUTTON, 14F, 1.7CM, 22CM TUBE PLACED IN THE FALL, REF #: GJ-1417-22, LOT#: 190808-017, EXP.07/01/2022. PLASTIC RING WHERE FEEDING SET CONNECTS FELL OUT PREVENTING PARENT FROM BEING ABLE TO CONNECT FEEDING SET. TUBE EMERGENTLY HAD TO BE REPLACED. THIS HAS HAPPENED WITH THIS TYPE OF TUBE IN THE PAST. PROCEDURE: SMALL INTESTINAL ENDOSCOPY WITH CONVERSION OF PERCUTANEOUS GASTROSTOMY TUBE TO PERCUTANEOUS JEJUNOSTOMY TUBE. 3 MONTHS LATER: PREOP DX: JEJUNOSTOMY TUBE MALFUNCTION. PROCEDURE PERFORMED: SMALL INTESTINAL ENDOSCOPY WITH CONVERSION OF PERCUTANEOUS GASTROSTOMY TUBE TO PERCUTANEOUS JEJUNOSTOMY TUBE. PROCEDURE DETAIL: THE DEFECTIVE AMT 1.2 CM 14-FRENCH 22 CM TUBE WAS REMOVED AND THE GUIDE WIRE WAS PASS INTO STOMACH AND GRAP BY NON NEEDLE GRASPERS AND DRAGGED TO THE PYLORUS AND SECOND PORTION DUODENUM. EXPLANTED DEVICE RETAINED. CAN SHIP IF REQUESTED BY MANUFACTURER AND RECEIPT OF SHIPPING LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478761 G-JET® TRANSGASTRIC-JEJUNAL FEEDING DEVICE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. GJ-1417-22 190808-017

    Patients

    Seq Age Sex Outcome Treatment
    1 360 DA