BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LUMEN CVC KIT W/BLUE FLEXTIP CATHETER

    MDR report key: 1160943 · Received September 12, 2008

    Report

    Report Number
    MW5008302
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ARROW-HOWES, ARROW INTERNATIONAL
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT. REQUIRING A CVP LINE AS PT HAD NO VENOUS ACCESS. WHEN THE CVP LINE WAS THREADED THE J GUIDEWIRE SLIPPED INTO THE VEIN AND COULD NOT BE EXTRACTED. PT. TRANSFERRED TO UPSTATE MEDICAL UNIVERSITY IN SYRACUSE FOR INTERVENTIONAL RADIOLOGY FOR EXTRACTION OF THE J GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT W/BLUE FLEXTIP CATHETER CVP LINE DQO ARROW-HOWES, ARROW INTERNATIONAL AK-14703-SP RFB056315

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention