BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE TRAY KIT

    MDR report key: 701721 · Received April 17, 2006

    Report

    Report Number
    2242445-2006-00020
    Event Type
    Injury
    Date Received
    April 17, 2006
    Date of Event
    December 21, 2005
    Report Date
    April 17, 2006
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PORT/CATHETER WERE INSERTED IN 2005. ON 12/21/2005, DURING INFUSION, A LEAK WAS NOTED IN THE MIDDLE OF THE CATHETER. THE PORT/CATHETER WERE REMOVED. IT IS UNK IF A NEW PORT/CATHETER WERE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE TRAY KIT THEREX IMPLANTABLE PORTS LJT ARROW INTERNATIONAL, INC. NA MF5038304

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention