BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYURETHANE CONTRAST INJECTION LINE

    MDR report key: 2002559 · Received January 28, 2011

    Report

    Report Number
    1721504-2011-00030
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K932251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED DEVICE HAD THE ROTATOR FULLY IN-TACT, NOT MATCHING COMPLAINT DETAILS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE WAS VISUALLY INSPECTED AND PRESSURE TESTED. THE DEVICE WAS WITHIN SPECIFICATIONS. EVALUATION: METHOD: THE DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING A LEFT VENTRICULOGRAM PROCEDURE. THE INJECTION WAS SET AT 10CC FOR 24CC TOTAL AND 1000 PSI. THERE WAS SPRAY. NO PATIENT 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. H186063

    Patients

    Seq Age Sex Outcome Treatment
    1 5FR 110CM .038 PIGTAIL CATHETER| CONTRAST MEDIA