BEUDAMED
    FDA Adverse Event Summary report: N

    AMT G-JET

    MDR report key: 6212430 · Received December 29, 2016

    Report

    Report Number
    1526012-2016-00018
    Date Received
    December 29, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 3, 2016
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K123716
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE PROVIDED INFORMATION, THE INCIDENT 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. ANALYSIS OF THE RETURNED DEVICE CONSISTED OF A VISUAL AND FUNCTIONAL EVALUATION, AS WELL AS A DEVICE HISTORY REVIEW. IT WAS DETERMINED THAT THE INTERLOCK DETACHED DUE TO PROLONGED/HARSH USE AND/OR EXCESSIVE FORCE AND THE VALVE LEAKAGE WAS CAUSED BY A RESIDUE BUILDUP INSIDE THE VALVE. THE VALVE PERFORMED AS INTENDED ONCE THE RESIDUE WAS REMOVED. THE PROLONGED/HARSH USE AND FAILURE TO APPROPRIATELY CLEAN AND MAINTAIN THE DEVICE CONTRIBUTED TO THIS EVENT AND IT IS NOT BELIEVED TO HAVE RESULTED FROM A MANUFACTURING DEFECT. (B)(4).

    Description of Event or Problem · 1

    LEAKING AMT G-J TUBE WHEN IN USE AT ONE OF THE PORTS. PORT VALVE NOT IN PLACE OR INCOMPETENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863811 AMT G-JET LOW PROFILE GASTRIC-JEJUNAL ENTERAL TUBE KNT APPLIED MEDICAL TECHNOLOGY, INC. 15121650

    Patients

    Seq Age Sex Outcome Treatment
    1