BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE FLEXIBLE, CONTRAST INJECTION LINE

    MDR report key: 1621358 · Received February 12, 2010

    Report

    Report Number
    1721504-2010-00036
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 18, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE EVAL IS NOT COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. DEVICE HISTORY RECORDS WAS REVIEWED, COMPLAINT DATA BASE WAS REVIEWED. CONCLUSIONS: THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADD'L INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT DURING A VENTRICULOGRAM PROCEDURE THE ROTATOR ON THE INJECTOR TUBING RUPTURED. NO CONTRAST WAS SPRAYED ON THE LAB STAFF. NO HARM OR INJURY TO THE PT WAS REPORTED.

    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. F657301

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA