BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2182237 · Received July 12, 2011

    Report

    Report Number
    1721504-2011-00222
    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
    DQO
    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. 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. THE PHYSICIAN HELD THE BROKEN DEVICE TOGETHER AND COMPLETED THE PROCEDURE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H112173

    Patients

    Seq Age Sex Outcome Treatment
    1