BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE CONTRAST INJECTION LINE

    MDR report key: 1881842 · Received October 8, 2010

    Report

    Report Number
    1721504-2010-00322
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION/ INVESTIGATION. THE DEVICE RECORD WAS REVIEWED AND FOUND ONE EXCEPTION DOCUMENT FOR THIS LOT. THE EXCEPTION WAS FOR ONE DEVICE FAILING PRESSURE TEST. THE LOT WAS SAMPLED AND RE-TESTED. SAMPLE DEVICES HAD 100% PASS OF SECONDARY PRESSURE TEST. NO OTHER EXCEPTIONS FOUND IN DEVICE HISTORY RECORD. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN AN EVALUATION IS COMPLETED. EVALUATION METHOD: HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CONNECTOR FAILED AFTER BEING CONNECTED TO THE CONTRAST INJECTOR SPRAYING THE LAB WITH CONTRAST. NO HARM OR INJURY WAS REPORTED.

    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. F698223

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA