BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR, PVC CONTRAST INJECTION LINE

    MDR report key: 1586581 · Received January 12, 2010

    Report

    Report Number
    1721504-2010-00004
    Event Type
    Malfunction
    Date Received
    January 12, 2010
    Date of Event
    November 18, 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 EVAL: ACTUAL DEVICE DISCARDED AT HOSPITAL AND NOT AVAILABLE FOR EVAL. CONCLUSIONS: OTHER, A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN EVAL IS COMPLETED.

    Description of Event or Problem · 1

    ROTATOR BROKE DURING A LEFT VENTRICULOGRAM PROCEDURE AT 800PSI.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA