BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARROW QUAD LUMEN CENTRAL LINE

    MDR report key: 552590 · Received April 1, 2004

    Report

    Report Number
    552590
    Event Type
    Other
    Date Received
    April 1, 2004
    Date of Event
    September 27, 2003
    Report Date
    April 1, 2004
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    AN ARROW QUAD LUMEN CENTRAL LINE WAS IN PLACE. THE BLUE PORT AND THE WHITE PORT WERE LEAKING AT THE INSERTION SITE AND UNDER THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW QUAD LUMEN CENTRAL LINE CENTRAL LINE DQO ARROW INTERNATIONAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR