BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE CONTRAST INJECTION LINE

    MDR report key: 1882866 · Received October 15, 2010

    Report

    Report Number
    1721504-2010-00326
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    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. COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. EVALUATION; METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATA BASE WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ROTATOR CAME APART DURING POWER INJECTION. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER HAS REPORTED THIS TYPE OF EVENT HAS HAPPENED NUMEROUS TIMES BUT DID NOT PROVIDE SPECIFIC DETAIL FOR NUMBER OF EVENTS OR ADDITIONAL CLINICAL INFORMATION. THEREFORE, THIS SINGLE FORM FDA 3500A REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYURETHANE CONTRAST INJECTION LINE DISPLAY, CATHODE-RAY TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. H127282

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER| CONTRAST MEDIA| MEDRAD INJECTOR