BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1994315 · Received January 14, 2011

    Report

    Report Number
    1721504-2011-00012
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL/INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR ON THE END OF THE MANIFOLD BROKE DURING USE. THE ROTATOR WAS CONNECTED TO A STOPCOCK. THE MANIFOLD WAS NOT STRUCK WITH ANYTHING HARD, THE TECH WAS TAPPING THE MANIFOLD WITH HIS FINGER WHEN THE ROTATOR BROKE. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC FPA MERIT MEDICAL SYSTEMS, INC. H159195

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA