BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE CONTRAST INJECTION LINE

    MDR report key: 1644012 · Received March 23, 2010

    Report

    Report Number
    1721504-2010-00062
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    February 26, 2010
    Report Date
    February 26, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. THIS DEVICE DOES NOT CONTAIN A 3-WAY STOPCOCK AS PART OF THE ASSEMBLY. THE DEVICE DOES CONTAIN A ROTATING ADAPTER. THIS WILL BE CONFIRMED WHEN THE DEVICE IS RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. COMPLAINT DATABASE REVIEW FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. DEVICE HISTORY RECORD WAS REVIEWED. COMPLAINT DATABASE WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE 3-WAY STOPCOCK CAN SEPARATE AND CRACK AT THE CONNECTION UNDER HIGH PRESSURE. THE O-RING SEPARATES FROM THE TUBING AT THE FEMALE JUNCTION. ONCE SEPARATED CONTRAST FLOWS OUT AS TUBING FALLS TO FLOOR. THERE WAS NO REPORTS OF HARM OR INJURY.

    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. F619620

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA