BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1404384 · Received June 16, 2009

    Report

    Report Number
    MW5011538
    Event Type
    Other
    Date Received
    June 16, 2009
    Date of Event
    May 22, 2009
    Report Date
    June 16, 2009
    Manufacturer
    BECTON DICKINSON JOHNSON INFUSION THERAPY INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF WERE UNABLE TO REMOVE SHEATH AFTER IV NEEDLE WAS IN PLACE. HAD TO REMOVE ENTIRE DEVICE AND AT THAT TIME, IT WAS DISCOVERED THAT CATHETER WAS BENT BACK FROM NEEDLE ITSELF. ANOTHER IV HAD TO BE STARTED. THERE HAVE BEEN NO FURTHER PRODUCT PROBLEMS WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * IV CATHETER FOZ BECTON DICKINSON JOHNSON INFUSION THERAPY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other