BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNTAIN INFUSION SYSTEM WITH SQUIRT

    MDR report key: 2182249 · Received July 12, 2011

    Report

    Report Number
    1721504-2011-00220
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K925419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE EVAL HAS NOT BEEN COMPLETED. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL: CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ROTATOR ON THE HEMOSTASIS VALVE BROKE DURING USE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNTAIN INFUSION SYSTEM WITH SQUIRT CATHETER, CONTINUOUS FLUSH DTL MERIT MEDICAL SYSTEMS, INC. F694625

    Patients

    Seq Age Sex Outcome Treatment
    1