BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI-LUMEN CVC KIT WITH BLUE FLEXTIP CATHETER

    MDR report key: 1870906 · Received September 28, 2010

    Report

    Report Number
    1870906
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    July 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMERGENCY DEPARTMENT (ED) PHYSICIAN USED THE ARROW CENTRAL LINE KIT TO INITIALLY FIND THE FEMORAL VEIN AND PLACED THE WIRE BUT THE DILATOR FRAYED AT THE POINT OF TRYING TO ENTER INTO THE SKIN, EVEN THOUGH A NICK WAS MADE IN THE SKIN WITH A #11 BLADE. THEN ED PHYSICIAN SWITCHED OVER TO A DIFFERENT MANUFACTURER KIT AND WAS ABLE TO USE THEIR DILATOR OVER THE WIRE AND PLACED IT EASILY INTO THE FEMORAL VEIN AND THEN PLACED A TRIPLE-LUMEN CENTRAL LINE INTO THE VEIN, REMOVED THE WIRE, GOOD ASPIRATION OF BLOOD IN ALL PORTS, AND FLUSHED ALL PORTS AND STAPLED IT INTO PLACE AND COVERED IT WITH A STERILE TRANSPARENT DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW MULTI-LUMEN CVC KIT WITH BLUE FLEXTIP CATHETER CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC * RF0022039

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NO OTHER THERAPIES