BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2033719 · Received February 11, 2011

    Report

    Report Number
    1721504-2011-00047
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    December 3, 2010
    Report Date
    January 18, 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 EVALUATION: TWO USED SUSPECT DEVICES WERE RETURNED FOR EVALUATION. THE DEVICES WERE EXAMINED VISUALLY AND THE COMPLAINT WAS CONFIRMED. THE ROTATOR WAS SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING ON BOTH DEVICES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE ROOT CAUSES OF THE FAILURE ARE ATTRIBUTED TO THE MANUFACTURING BONDING PROCESS. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. THESE SUBASSEMBLIES WAS BUILT PRIOR TO IMPLEMENTATION OF THE NOTED CORRECTIVE ACTIONS. EVALUATION METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR ON THE STOPCOCK BROKE DURING AN ABDOMINAL ANGIOGRAPHIC PROCEDURE AT 300 PSI. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF TWO REPORTS FOR THIS COMPLAINT: 1721504-2011-00046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DTL MERIT MEDICAL SYSTEMS, INC. F721558

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA