BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2043419 · Received February 25, 2011

    Report

    Report Number
    1721504-2011-00075
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 3, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVAL. UPON VISUAL INSPECTION THE COMPLAINT WAS CONFIRMED. THE ROTATOR WAS SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATA BASE WAS REVIEWED AND FOUND ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MFG BONDING PROCESS. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. THIS SUBASSEMBLY WAS BUILT PRIOR TO IMPLEMENTATION OF THE NOTED CORRECTIVE ACTIONS. EVAL: METHOD - DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATA BASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR ON THE STOPCOCK BROKE DURING USE. THE CUSTOMER REPORTED THAT THE EVENT OCCURRED FIVE TIMES. INJECTOR SETTINGS: FLOW 9 ML/SEC, VOLUME 15 ML, PRESSURE 987 PSI. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF FIVE REPORTS FOR THIS EVENT: 1721504-2011-00076, 1721504-2011-00077, 1721504-2011-00078, 1721504-2011-00079.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DTL MERIT MEDICAL SYSTEMS, INC. H113066

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA