BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2356509 · Received November 16, 2011

    Report

    Report Number
    1721504-2011-00381
    Event Type
    Malfunction
    Date Received
    November 16, 2011
    Date of Event
    October 14, 2011
    Report Date
    October 20, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE USER REPORTED A SECOND LOT NUMBER, H212178, EXPIRATION DATE: 06/30/2013, DEVICE MANUFACTURE DATE: 03/2011. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A NEUROLOGICAL PROCEDURE THE ROTATOR ON THE HEMOSTASIS VALVE BROKE DURING A HAND INJECTION. THE USER REPORTED FOUR DEFECTIVE DEVICES. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF FOUR REPORTS FOR THIS COMPLAINT. 1721504-2011-00379, 00380, 00382.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. H240824

    Patients

    Seq Age Sex Outcome Treatment
    1