BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT HEMOSTASIS VALVE

    MDR report key: 1934327 · Received November 23, 2010

    Report

    Report Number
    9616662-2010-00056
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 26, 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

    THE EVALUATION/INVESTIGATION IS NOT COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE DEVICE WAS EXAMINED ON (B)(4) 2010 AND FOUND TO HAVE THE ROTATOR HOUSING SEPARATED FROM THE ROTATOR COLLAR. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THERE WAS A LEAK AT THE 'Y' CONNECTION. 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. W147863

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA