BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR, PVC CONTRAST INJECTION LINE

    MDR report key: 1900582 · Received October 29, 2010

    Report

    Report Number
    1721504-2010-00361
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. EVALUATION : CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE HIGH PRESSURE TUBING BLEW OFF DURING INJECTION. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR, PVC CONTRAST INJECTION LINE DISPLAY, CATHODE-RAY-TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. F667706

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA