BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE CONTRAST INJECTION LINE

    MDR report key: 1881819 · Received October 8, 2010

    Report

    Report Number
    1721504-2010-00319
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    March 4, 2010
    Report Date
    September 15, 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 DEVICE WILL NOT BE RETURNED FOR EVALUATION/ INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN AN EVALUATION IS COMPLETED. EVALUATION CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULOGRAM PROCEDURE. THE BROKEN ROTATOR WAS DISCARDED AT THE HOSPITAL. NO HARM OR INJURY WAS REPORTED.

    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