BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAM JUNCTIONAL TOURNIQUET (SJT)

    MDR report key: 4232479 · Received October 24, 2014

    Report

    Report Number
    3023316-2014-00002
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 29, 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
    UK
    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 AXILLA STRAP (AUXILIARY STRAP) BROKE. ACCORDING TO THE CLIENT FACTS, THEY USED THE TOURNIQUET PROPERLY DURING A MEDICAL EMERGENCY LESSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677906 SAM JUNCTIONAL TOURNIQUET (SJT) JUNCTIONAL TOURNIQUET DXC SAM MEDICAL PRODUCTS 102-0175-00 05/15/2013

    Patients

    Seq Age Sex Outcome Treatment
    1