BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE FLEXIBLE, CONTRAST INJECTION LINE

    MDR report key: 1587615 · Received January 13, 2010

    Report

    Report Number
    1721504-2010-00008
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 2, 2009
    Report Date
    December 14, 2009
    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 REVEAL ANY EXCEPTION DOCUMENTS. 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 TO FAILURE. COMPLAINT DATA WILL BE MONITORED TO VERIFY EFFECTIVENESS OF CORRECTIVE ACTIONS TAKEN. DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATA BASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE IMMEDIATELY AFTER INFUSION STARTED DURING ANGIOGRAPHY PROCEDURE. FLOW RATE - 10ML/SEC, PRESSURE - 900 PSI. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCITE FLEXIBLE, CONTRAST INJECTION LINE DISPLAY, CATHODE-RAY TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. F675210

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA