BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAM JUNCTIONAL TOURNIQUET (SJT)

    MDR report key: 4602849 · Received March 9, 2015

    Report

    Report Number
    3023316-2015-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2015
    Date of Event
    July 16, 2014
    Report Date
    March 3, 2015
    Manufacturer
    SAM MEDICAL PRODUCTS
    Product Code
    DXC
    PMA / PMN Number
    K131561
    Removal / Correction Number
    Z-0133-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS DESCRIBED BY THE INITIAL REPORTER "THE BUCKLE/CLIP FOR THE AXILLA ATTACHMENT BROKE DURING PREPARATION FOR TDY TRAINING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161806 SAM JUNCTIONAL TOURNIQUET (SJT) DXC SAM MEDICAL PRODUCTS 102-0175-00

    Patients

    Seq Age Sex Outcome Treatment
    1