BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS SERIES STOPCOCKS

    MDR report key: 1943986 · Received December 3, 2010

    Report

    Report Number
    1721504-2010-00407
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 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

    DEVICE EVAL, THE DEVICE EVAL HAS NOT BEEN COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL METHOD , DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSION, A F/U REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE STOPCOCK BROKE DURING INJECTION AT 700 PSI. NO REPORT OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS SERIES STOPCOCKS ADAPTER, STOPCOCK MANIFOLD FITTING DTL MERIT MEDICAL SYSTEMS, INC. F735808

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA