BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRESPONDER TOURNIQUET

    MDR report key: 10864978 · Received November 18, 2020

    Report

    Report Number
    3011137372-2020-00251
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 21, 2020
    Report Date
    October 28, 2020
    Manufacturer
    PYNG MEDICAL
    Product Code
    GAX
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CERTIFICATE OF CONFORMANCE FOR LOT 240816 WAS REVIEWED AS PART OF THIS COMPLAINT INVESTIGATION. NO MANUFACTURING ISSUES WERE FOUND. THE IFU PROVIDED WITH THIS PRODUCT NOTIFIES THE USER TO RESET THE TOURNIQUET BEFORE EACH APPLICATION. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE PROBABLE CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED WITH NO RELEVANT FINDINGS. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REGARDING APPLICATION OF DEVICE, IT FAILED WHEN SECURING FOR THE FIRST TIME. IT WAS APPLIED CORRECTLY, SECURED, THE TURN KEY ROTATED UNTIL TIGHT. THE DEVICE CLICKED SEVERAL TIMES MADE A SNAPPING SOUND AND WENT LOOSE. A SECOND DEVICE WAS THEN USED INCORRECTLY AND A THIRD USED WITH DESIRED OUTCOME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REGARDING APPLICATION OF DEVICE, IT FAILED WHEN SECURING FOR THE FIRST TIME. IT WAS APPLIED CORRECTLY, SECURED, THE TURN KEY ROTATED UNTIL TIGHT. THE DEVICE CLICKED SEVERAL TIMES MADE A SNAPPING SOUND AND WENT LOOSE. A SECOND DEVICE WAS THEN USED INCORRECTLY AND A THIRD USED WITH DESIRED OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328640 MATRESPONDER TOURNIQUET NONPNEUMATIC TOURNIQUET GAX PYNG MEDICAL 240816

    Patients

    Seq Age Sex Outcome Treatment
    1