BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUAD LUMEN CVC SUPER KIT

    MDR report key: 535475 · Received June 25, 2004

    Report

    Report Number
    535475
    Event Type
    Other
    Date Received
    June 25, 2004
    Date of Event
    June 16, 2004
    Report Date
    June 18, 2004
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE RECENT OCCURRENCES (DIFFERENT PTS) OF "LEAKING" FROM THE PROXIMAL LINE OF THE 4 LUMEN CENTRAL VENOUS CATHETERS WERE REPORTED AT THE SURGERY DEPARTMENT MEETING. THE INTRAVENOUS FLUIDS APPARENTLY COME BACK OUT AT THE INSERTION SITE. THE SURGEONS FEEL THAT THE CATHETERS HAVE THE PROXIMAL INFUSION PORT TOO CLOSE TO THE PT'S SKIN. THEY HAVE BEEN TELLING THE STAFF TO USE ANOTHER PORT AND THE FLUIDS HAVE INFUSED FINE. OF COURSE, THIS LIMITS THE 4 LUMEN CATHETER TO ONLY A 3 LUMEN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUAD LUMEN CVC SUPER KIT CENTRAL VENOUS CATHETER DQO ARROW INTERNATIONAL INC * AK25854-SK

    Patients

    Seq Age Sex Outcome Treatment
    1 *