BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE CONTRAST INJECTION LINE

    MDR report key: 1633931 · Received March 5, 2010

    Report

    Report Number
    1721504-2010-00054
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    January 27, 2010
    Report Date
    February 9, 2010
    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

    DEVICE EVALUATION: THE 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 DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE ROOT CAUSE OF THE MALFUNCTION IS ATTRIBUTED TO FAILURE OF THE ADHESIVE BOND BETWEEN THE ROTATOR HOUSING AND THE ROTATOR COLLAR. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. 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 BROKE AT 900 PSI. NO ADDITIONAL INFORMATION PROVIDED. NO REPORT OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYURETHANE CONTRAST INJECTION LINE DISPLAY, CATHODE-RAY-TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. F679458

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA