BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE FLEXIBLE, CONTRAST INJECTION LINE

    MDR report key: 1881834 · Received October 8, 2010

    Report

    Report Number
    1721504-2010-00313
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. EVALUATION METHOD, THE DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSION: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE WHEN PRESSURE BUILT UP DURING A ANGIOGRAPHIC PROCEDURE. THERE WAS NO REPORT OF HARM OR INJURY. THE CUSTOMER REPORTED FOUR (4) DEFECTIVE DEVICES BUT WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION OR CLINICAL DETAILS FOR THE ADDITIONAL EVENTS. THIS SINGLE FORM FDA 3500A REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCITE FLEXIBLE, CONTRAST INJECTION LINE DISPLAY, CATHODE-RAY TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. F697930

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA