BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAM EXTREMITY TOURNIQUET

    MDR report key: 16398930 · Received February 17, 2023

    Report

    Report Number
    3023316-2022-00001
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    June 23, 2022
    Report Date
    July 22, 2022
    Manufacturer
    SAM MEDICAL PRODUCXTS
    Product Code
    GAX
    UDI-DI
    00822045000209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS CONDUCTED EVALUATING THE PORTION OF THE DEVICE RETURNED . USE HISTORY OF THE DEVICE COULD NOT BE CONFIRMED. THE LOT NUMBER WAS NOT AVAILABLE ON THE PORTION OF THE DEVICE RETURNED. THE FRACTURE PATTERN ON THE REMAINING BUCKLE COMPONENT WAS ABLE TO BE CONSISTENTLY RECREATED ACROSS MULTIPLE LOTS BUT ONLY BY USING TOOLS TO INCREASE THE MECHANICAL ADVANTAGE TO THE WINDLASS. FURTHER CHARACTERIZATION OF THE FAILURE MODE IS UNDER INVESTIGATION, BUT THE FAILURE CAN ONLY BE RECREATED AT PRESSURES FAR EXCEEDING ACCEPTABLE CLINICAL LIMB OCCLUSION PRESSURES. SAM MEDICAL WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS PRODUCT FOR ANY SIGNIFICANT TRENDS.

    Description of Event or Problem · 0

    A POLICE OFFICER ATTEMPTED TO PLACE A SAM XT ON THE RIGHT THIGH OF A PATIENT WITH AN OPEN COMPOUND TIBIA/FIBIA FRACTURE SUSTAINED IN CAR VS. BICYCLE COLLISION AFTER THE PREVIOUSLY APPLIED CAT TOURNIQUET WAS NOT OCCLUDING BLEEDING. WHEN THE SAM XT WINDLASS WAS TIGHTENED, THE BUCKLE FRAME BROKE. A SECOND TOURNIQUET WAS PLACED ON THE THIGH, AND THE BLEEDING STOPPED. THE PATIENT WAS TRANSPORTED TO HOSPITAL BY AMBULANCE FOR TREATMENT OF INJURIES. THE BROKEN XT WAS RETAINED FROM THE SCENE FOR INVESTIGATION, BUT THE BROKEN BUCKLE WAS LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120061 SAM EXTREMITY TOURNIQUET SAM XT TACTICAL BLACK GAX SAM MEDICAL PRODUCXTS XT600-BK-EN UNKNOWN 00822045000209

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other