BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAM JUNCTIONAL TOURNIQUET (SJT)

    MDR report key: 4232501 · Received October 24, 2014

    Report

    Report Number
    3023316-2014-00003
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 23, 2014
    Manufacturer
    SAM MEDICAL PRODUCTS
    Product Code
    DXC
    PMA / PMN Number
    K131561
    Removal / Correction Number
    3023316-09/25/2014-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE WAS CONCLUDED TO BE DUE TO A MANUFACTURING FLAW IN THE BROKEN SNAP HOOK.

    Description of Event or Problem · 1

    THE PLASTIC HOOK (SNAP HOOK) FROM THE AUXILIARY STRAP BROKE WHILE THE SJT WAS BEING APPLIED, AS PART OF A SIMULATED TRAINING EXERCISE, TO A VOLUNTEER. IT WAS NOT USED IN A CLINICAL SETTING OR APPLIED TO A PATIENT, SO THERE WAS NO POTENTIAL FOR HARM OR COMPROMISE TO TREATMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677969 SAM JUNCTIONAL TOURNIQUET (SJT) JUNCTIONAL TOURNIQUET DXC SAM MEDICAL PRODUCTS 102-0175-00 03/31/2014

    Patients

    Seq Age Sex Outcome Treatment
    1