BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT HEMOSTASIS VALVE

    MDR report key: 1963524 · Received December 20, 2010

    Report

    Report Number
    9616662-2010-00062
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K925419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE EVAL IS IN PROCESS. THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL METHOD: LOT NUMBER WAS NOT PROVIDED. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. CONCLUSIONS: OTHER, A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE AT THE END. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT HEMOSTASIS VALVE ADAPTOR, STOPCOCK, MANIFOLD FITTING DTL MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA