BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAMIC HIGH PRESSURE CONTRAST INJECTION LINE 30 INCHES

    MDR report key: 1881889 · Received October 20, 2010

    Report

    Report Number
    MW5017850
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 11, 2010
    Manufacturer
    NAVILYST MEDICAL, INC
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A CARDIAC CATHETERIZATION. IMMEDIATELY AFTER ACTIVATION OF THE AUTO-INJECTOR FOR AN AORTIC ROOT IMAGE, NO DYE WAS SEEN ON FLUOROSCOPY. THE PT WAS ASSESSED AND FOUND TO HAVE SLOW SPEECH, BUT ABLE TO FOLLOW COMMANDS, AWAKE, ALERT, ORIENTED. PUPILS WERE EQUAL, REACTIVE TO LIGHT AT 6MM. VITAL SIGNS WERE STABLE. SLOW SPEECH QUICKLY RESOLVED. PROCEDURE STOPPED AND PT TREATED PER STROKE PROTOCOLS. PT ADMITTED TO INTENSIVE CARE FOR OBSERVATION AND DISCHARGED TO HOME 24 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAMIC HIGH PRESSURE CONTRAST INJECTION LINE 30 INCHES NONE DXT NAVILYST MEDICAL, INC 4023291

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization EXP: 08/2012| MEDRAD AUTO-INJECTOR: MODEL PRM MARK 5,| BOSTON SCIENTIFIC| SYRINGE: 150 ML, LOT 60210123| (B)(4)| (B)(4)| LOT: 50542729| IMPULSE FLEXTRUSION SHAFT ANGIOGRAPHIC CATHETER 6F| EXP: 02/2013| (B)(4)| MFG: (B)(4)| SERIAL #(B)(4)