BEUDAMED
    FDA Adverse Event Other Summary report: N

    BUNEGIN-ALBIN AIR ASPIRATION CVP CATHETER

    MDR report key: 506220 · Received January 13, 2004

    Report

    Report Number
    1820334-2004-00017
    Event Type
    Other
    Date Received
    January 13, 2004
    Date of Event
    June 1, 2003
    Report Date
    December 17, 2003
    Manufacturer
    COOK INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THROMBUS OF MORE THAN 2CM IN DISTAL PART OF CATHETER. DURING THE OPERATION, IT WAS IMPOSSIBLE TO ASPIRATE AIR, RESULTING IN AIR EMBOLIZATION. PT EXPERIENCED DIFFICULTY FOR A PERIOD OF MORE THAN ONE DAY IN BUILDING RIGHT CARDIAC OUTPUT. PT IS DOING WELL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUNEGIN-ALBIN AIR ASPIRATION CVP CATHETER CATHETER DQO COOK INC. NA F1358718

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other