BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE, FLEXIBLE BRAIDED TUBING

    MDR report key: 2062455 · Received March 18, 2011

    Report

    Report Number
    1721504-2011-00101
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 24, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE CUSTOMER HAS NOT INDICATED IF THIS WAS THE INITIAL USE OF THE DEVICE. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. EVAL, METHOD: DEVICE HISTORY RECORD WAS REVIEWED. CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING AN ANGIOGRAPHIC PROCEDURE AT 900 PSI. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED THREE DEFECTIVE DEVICES BUT DID NOT PROVIDE ANY FURTHER INFO OR CLINICAL DETAILS FOR THE ADD'L EVENTS. THE CUSTOMER IS NOT RETURNING ANY DEVICES FOR EVAL. THEREFORE THIS SINGLE FORM FDA 3500A WILL BE SUBMITTED FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYURETHANE, FLEXIBLE BRAIDED TUBING DISPLAY, CATHODE-RAY TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. F693814

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA