BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAM JUNCTIONAL TOURNIQUET (SJT)

    MDR report key: 4081107 · Received August 29, 2014

    Report

    Report Number
    3023316-2014-00001
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 7, 2014
    Manufacturer
    SAM MEDICAL PRODUCTS
    Product Code
    DXC
    PMA / PMN Number
    K131561
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE WAS CONCLUDED TO BE DUE TO MANUFACTURING FLAW IN BROKEN SNAPHOOK. CONCLUSION: THE MANUFACTURING FLAW REPRESENTED BY THE "BUBBLE" IN THE PLASTIC MATERIAL CORRESPONDS DIRECTLY WITH THE POINT OF FRACTURE AND IT CAN BE CONCLUDED THAT ITS PRESENCE LED TO A SIGNIFICANT REDUCTION IN STRUCTURAL INTEGRITY, WHICH IN TURN LED TO THE FRACTURING OF THE PART.

    Description of Event or Problem · 1

    AS DESCRIBED BY THE INITIAL REPORTER: "I OPENED A NEW SAM JUNCTIONAL TOURNIQUET (SJT) TO BE USED FOR TRAINING PURPOSES. THE FIRST APPLICATION WAS TO DEMONSTRATE AXIAL USE. THE CASUALTY WAS STANDING DURING DEMONSTRATION. THE PELVIC BELT WAS PLACED AROUND THE CASUALTY'S CHEST AND TIGHTENED. THE AUXILIARY STRAP SUPPORT WAS THEN CONNECTED TO THE BELT GOING OVER THE CASUALTY'S RIGHT SHOULDER. I WAS TIGHTENING THE AUXILIARY STRAP SUPPORT TO ENSURE THE TARGET COMPRESSION DEVICE WOULD BE ABLE TO APPLY ENOUGH PRESSURE TO STOP RADIAL PULSE. WHILE TIGHTENING, THE D-RING ON THE AUXILIARY STRAP SUPPORT BROKE." NOTES: "AXIAL USE" MEANS PRESSURE BEING APPLIED TO THE AXILLA ARTERY; THE "D-RING" ON THE AUXILIARY STRAP IS A BLACK PLASTIC SNAPHOOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527640 SAM JUNCTIONAL TOURNIQUET (SJT) JUNCTIONAL TOURNIQUET DXC SAM MEDICAL PRODUCTS 102-0175-00 02/25/2014

    Patients

    Seq Age Sex Outcome Treatment
    1