BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS SERIES STOPCOCKS

    MDR report key: 1881843 · Received October 8, 2010

    Report

    Report Number
    1721504-2010-00316
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL/ INVESTIGATION. A F/U REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL IS COMPLETED. EVAL: CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    THE STOPCOCK ROTATOR BROKE ON THE SECOND INJECTION. FLOW-2ML, VOLUME- 6ML, PRESSURE LIMIT- 850 PSI. NO REPORT OF HARM OR INJURY. THE CUSTOMER REPORTED TWO DEFECTIVE DEVICES BUT DID NOT PROVIDE ADDITIONAL DETAILS OR CLINICAL INFO FOR THE ADD'L EVENT. THEREFORE, THIS SINGLE FORM FDA 3500A 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. F777885

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA