BEUDAMED
    FDA Adverse Event Summary report: N

    AMT G-JET

    MDR report key: 6212393 · Received December 29, 2016

    Report

    Report Number
    1526012-2016-00017
    Date Received
    December 29, 2016
    Date of Event
    October 31, 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

    THIS REPORT IS IN RESPONSE TO UF REPORT # (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. THE JEJUNAL DUCKBILL LEAK WAS DETERMINED TO BE CAUSED BY A RESIDUE BUILDUP INSIDE THE VALVE AND THE VALVE PERFORMED AS INTENDED ONCE THE RESIDUE WAS REMOVED. THE FAILURE TO APPROPRIATELY CLEAN AND MAINTAIN THE DEVICE CONTRIBUTED TO THIS EVENT AND IT IS NOT BELIEVED TO HAVE RESULTED FROM A MANUFACTURING DEFECT. WE HAVE ASSIGNED COMPLAINT NUMBER (B)(4) TO THIS REPORT.

    Description of Event or Problem · 1

    AMT GJ TUBE WAS LEAKING AT ONE OF ITS PORTS. MANUFACTURER RESPONSE FOR AMT G_J TUBE, AMT GJ TUBE 14 FR 1. 0CM , 15CM (PER SITE REPORTER): PROVIDING A SHIPPING LABEL FOR SHIPPING. STATED THESE DEVICES GENERALLY ARE FOR SHORT TERM 3-4 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863229 AMT G-JET LOW PROFILE GASTRIC-JEJUNAL ENTERAL TUBE KNT APPLIED MEDICAL TECHNOLOGY, INC. 160906-297

    Patients

    Seq Age Sex Outcome Treatment
    1