BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR, PVC CONTRAST INJECTION LINE

    MDR report key: 1650122 · Received March 25, 2010

    Report

    Report Number
    1721504-2010-00067
    Event Type
    Malfunction
    Date Received
    March 25, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 3, 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: DEVICE HAS NOT BEEN RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. COMPLAINT DATABASE REVIEW FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED. METHOD - OTHER, DEVICE HISTORY RECORD WAS REVIEWED. COMPLAINT DATABASE WAS REVIEWED. CONCLUSIONS - OTHER, A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULOGRAM PROCEDURE WHILE USING A POWER INJECTOR. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR, PVC CONTRAST INJECTION LINE DISPLAY, CATHODE-RAY TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. F577707

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA