BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLEPLAY LARGE BORE HEMOSTASIS VALVE

    MDR report key: 3252454 · Received July 24, 2013

    Report

    Report Number
    9616662-2013-00020
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS INC
    Product Code
    DTL
    PMA / PMN Number
    K925419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL. THE USER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE THUMBWHEEL ON THE HEMOSTASIS VALVE COULD NOT BE TIGHTENED AND WOULD TURN FREELY. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345808 DOUBLEPLAY LARGE BORE HEMOSTASIS VALVE ADAPTOR, STOPCOCK, MANIFOLD, FITTING DTL MERIT MEDICAL SYSTEMS INC K346333

    Patients

    Seq Age Sex Outcome Treatment
    1