BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2093234 · Received April 14, 2011

    Report

    Report Number
    1721504-2011-00141
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO USED SUSPECT DEVICES WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION THE COMPLAINT WAS CONFIRMED. THE ROTATOR WAS SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING ON ONLY ONE OF THE RETURNED DEVICES. NO DEFECT WAS FOUND ON THE SECOND RETURNED DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION AS TO IF THIS WAS THE INITIAL USE OF THE DEVICE. 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. METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR ON THE HIGH PRESSURE TUBING BROKE DURING USE. INJECTOR SETTINGS: 1-2 ML/SEC FOR A TOTAL OF 8 ML AT 750 PSI. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DXJ MERIT MEDICAL SYSTEMS, INC. F706545

    Patients

    Seq Age Sex Outcome Treatment
    1