BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2013815 · Received February 4, 2011

    Report

    Report Number
    1721504-2011-00045
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 13, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K913682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED VISUALLY AND THE COMPLAINT WAS CONFIRMED. THE ROTATOR WAS SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO EXCEPTION DOCUMENTS. THE COMPLAINT DATA BASE 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. THIS SUBASSEMBLY WAS BUILT PRIOR TO IMPLEMENTATION OF THE NOTED CORRECTIVE ACTIONS. COMPLAINT DATA WILL BE MONITORED TO VERIFY EFFECTIVENESS OF CORRECTIVE ACTIONS TAKEN. EVALUATION: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATA BASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR ON THE STOPCOCK BROKE DURING A TRANSCATHETER HEPATIC ARTERY CHEMOEMBOLIZATION. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. F756931

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA