BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2182250 · Received July 12, 2011

    Report

    Report Number
    1721504-2011-00221
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K913682
    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. 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 BROKE DURING USE. INJECTOR SETTINGS: 20 ML/SEC FOR A TOTAL OF 9.8 ML AT 834 PSI. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DXJ MERIT MEDICAL SYSTEMS, INC. H194436

    Patients

    Seq Age Sex Outcome Treatment
    1