BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROWGARD BLUE PLUS QUAD-LUMEN CVC KIT

    MDR report key: 2122839 · Received June 8, 2011

    Report

    Report Number
    2122839
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CENTRAL LINE INSERTION, NEEDLE BECAME UNATTACHED FROM HUB-LOOSE IN VEIN. LUCKILY THERE WAS STILL SMALL PORTION STILL ABOVE ENTRANCE TO VEIN SO ABLE TO RETRIEVE. NEAR MISS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROWGARD BLUE PLUS QUAD-LUMEN CVC KIT QUAD-LUMEN CENTRAL LINE INDWELLING CATHETER DQY ARROW INTERNATIONAL * RF9127470

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR