BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2013809 · Received February 4, 2011

    Report

    Report Number
    9616662-2011-00012
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE HAS NOT BEEN RECEIVED 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 EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PROBLEM WITH THE ROTATOR ON THE HEMOSTASIS VALVE. 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. W773838

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA