BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT G-J TUBE

    MDR report key: 3181373 · Received June 6, 2013

    Report

    Report Number
    3181373
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    February 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE G-J BUTTON WAS INSERTED UNDER FLUOROSCOPY ON A PATIENT. PLACEMENT WAS VERIFIED AND NO COMPLICATIONS WERE NOTED. THE FOLLOWING DAY, THE PATIENT WAS FOUND TO HAVE JEJUNAL PERFORATION. PATIENT RETURNED TO SURGERY FOR PERFORATION REPAIR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CONVERSION OF A GASTROSTOMY BUTTON TO A GASTROSTOMY/JEJUNAL BUTTON.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252017 AMT G-J TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC * 13020603

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO CARDIAC DRUGS