BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2800046 · Received October 17, 2012

    Report

    Report Number
    1125782-2012-00008
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. THE USER DID NOT INDICATE IF THIS WAS THE INITIAL USE OF THE DEVICE. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THE ROLLER CLAMP DOES NOT CLAMP THE TUBING PROPERLY. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. T369577

    Patients

    Seq Age Sex Outcome Treatment
    1