BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR, PVC CONTRAST INJECTION LINE

    MDR report key: 1934726 · Received November 29, 2010

    Report

    Report Number
    1721504-2010-00401
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 4, 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 SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. A F/U REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. EVALUATION METHOD: THE DEVICE HISTORY RECORD WAS REVIEWED, THE COMPLAINT DATA BASE WAS REVIEWED. CONCLUSIONS: OTHER, A F/U REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULOGRAM PROCEDURE. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED TWO DEFECTIVE DEVICES. THE CUSTOMER HAS NOT PROVIDED ANY INFO OR CLINICAL DETAILS FOR THE ADD'L EVENT. THE CUSTOMER IS NOT EXPECTED TO RETURN ANY DEVICES FOR EVALUATION. THIS SINGLE FORM FDA 3500A REPORT WILL BE SUBMITTED.

    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. F689520

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA