BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS SERIES STOPCOCKS

    MDR report key: 1881723 · Received October 11, 2010

    Report

    Report Number
    1721504-2010-00324
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE EVALUATION/INVESTIGATION IS NOT YET COMPLETE. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO EXCEPTION DOCUMENTS NOTED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVALUATION IS COMPLETED. METHOD - DEVICE HISTORY RECORD WAS RECEIVED. CONCLUSIONS - A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE STOPCOCK ROTATOR BROKE UNDER PRESSURE. NO REPORT OF HARM OR INJURY. THE CUSTOMER REPORTED 2 DEFECTIVE DEVICES BUT DID NOT PROVIDE DETAILS OR CLINICAL INFORMATION FOR THE ADDITIONAL EVENT. THEREFORE, THIS SINGLE REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS SERIES STOPCOCKS ADAPTER, STOPCOCK MANIFOLD FITTING DTL MERIT MEDICAL SYSTEMS, INC. H100535

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA