BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE FLEXIBLE, CONTRAST INJECTION LINE

    MDR report key: 1633933 · Received March 5, 2010

    Report

    Report Number
    1721504-2010-00053
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    January 27, 2010
    Report Date
    February 9, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: DEVICE EVALUATION IS IN PROGRESS. 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 DATA BASE WAS REVIEWED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ROTATOR ON THE HIGH PRESSURE TUBING BROKE AT 750 PSI. THERE WAS NO REPORT OF HARM OR INJURY. CUSTOMER REPORTED THAT 2 DEVICES WERE DEFECTIVE BUT HAS NOT PROVIDED ANY ADDITIONAL INFORMATION TO ENABLE US TO REPORT AN ADDITIONAL FORM FDA 3500A REPORT. THEREFORE, THIS SINGLE REPORT WILL BE SUBMITTED FOR THE COMPLAINT.

    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. F667697

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA