BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS SERIES STOPCOCKS

    MDR report key: 1931724 · Received November 22, 2010

    Report

    Report Number
    1721504-2010-00392
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICES HAVE NOT BEEN RECEIVED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED. EVAL: METHOD: DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR ON THE STOPCOCK BROKE WHILE INJECTING CONTRAST MEDIA DURING A LEFT VENTRICULOGRAM PROCEDURE. INJECTOR SETTINGS- 1000 PSI. NO REPORT OF HARM OR INJURY. THE CUSTOMER REPORTED SIX DEFECTIVE DEVICES BUT DID NOT PROVIDE ANY ADD'L INFO OR CLINICAL DETAILS FOR THE ADD'L EVENTS. THEREFORE, THIS SINGLE FORM FDA 3500A REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS SERIES STOPCOCKS ADAPTER, STOPCOCK, MANIFOLD FITTING DTL MERIT MEDICAL SYSTEMS, INC. F721068

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA - OMNIPAQUE 300| INJECTOR