BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVC, CLEAR, CONTRAST INJECTION TUBING

    MDR report key: 2062452 · Received March 18, 2011

    Report

    Report Number
    1721504-2011-00099
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE EVAL HAS NOT BEEN COMPLETED. THE CUSTOMER DID NOT REPORT A LOT NUMBER FOR THE SUSPECT DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE COMPLETED WITHOUT THE DEVICE LOT NUMBER. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL METHOD: DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED. CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULAR INJECTION AT 800 PSI. THERE WAS SPRAY. THE ATTENDING PHYSICIAN WAS SPRAYED TWICE. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER. NO HARM OR INJURY WAS REPORTED. THIS IS ONE OF THREE REPORTS FOR THIS EVENT: 1721504-2011-00098, 1721504-2011-00100.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1