BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3252451 · Received July 24, 2013

    Report

    Report Number
    9616662-2013-00022
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS INC
    Product Code
    DQO
    PMA / PMN Number
    K925419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE THUMBWHEEL ON THE HEMOSTASIS VALVE INCLUDED IN THE KIT COULD NOT BE TIGHTENED AND THAT BLOOD LEAKED FROM THE DEVICE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345807 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS INC K425952

    Patients

    Seq Age Sex Outcome Treatment
    1