BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR, PVC CONTRAST INJECTION LINE

    MDR report key: 1900198 · Received October 23, 2010

    Report

    Report Number
    1721504-2010-00333
    Event Type
    Malfunction
    Date Received
    October 23, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 27, 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 EVAL: THE DEVICE EVAL HAS NOT BEEN COMPLETED. EVAL: CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING ABDOMINAL ANGIOGRAPHY AT 360 PSI. NO HARM OR INJURY REPORTED. THE CUSTOMER REPORTED TWO (2) DEFECTIVE DEVICES BUT HAS NOT PROVIDED ANY ADD'L INFO OR CLINICAL DETAILS FOR THE ADD'L EVENTS. THE CUSTOMER IS TO RETURN TWO DEVICES.

    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. F699694

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA