BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS SERIES STOPCOCKS

    MDR report key: 1993877 · Received January 12, 2011

    Report

    Report Number
    1721504-2011-00011
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ROTATING CUFF OF THE STOPCOCK CAME OFF DURING HIGH PRESSURE INJECTION AT 900 PSI. CONTRAST MEDIUM WAS SPRAYED. NO REPORT OF HARM OR INJURY. THE CUSTOMER REPORTED 2 DEFECTIVE AND TWO 'DATE OF EVENT' DATES, (B)(6) 2010 AND (B)(6) 2010. THE CUSTOMER DID NOT PROVIDED ANY SPECIFIC INFO OR CLINICAL DETAILS FOR THE ADD'L EVENT. THE CUSTOMER IS EXPECTED TO RETURN ONE USED DEVICE. 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. F703500

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA