BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR, PVC CONTRAST INJECTION LINE

    MDR report key: 1943941 · Received December 3, 2010

    Report

    Report Number
    1721504-2010-00409
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL HAS NOT BEEN COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL: METHOD: DEVICE HISTORY RECORD WAS REVIEWED. 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 CONTRAST INJECTION. NO HARM OR INJURY REPORTED. THE CUSTOMER REPORTED 3 DEFECTIVE BUT COULD NOT PROVIDE ANY SPECIFIC INFO OR CLINICAL DETAILS FOR THE ADDITIONAL EVENTS. THEREFORE THIS SINGLE FORM FDA 3500A REPORT WILL BE FILED.

    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. F654230

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA