BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2298621 · Received October 14, 2011

    Report

    Report Number
    2298621
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 28, 2011
    Report Date
    October 14, 2011
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    NURSE WAS COVERING NEEDLE OF ECLIPSE BD BECTON, DICKINSON AND COMPANY NEEDLE AFTER GIVING A FLU VACCINE. SHE APPLIED PRESSURE ON THE DISTAL PORTION OF THE PINK SHEATH WITH HER INDEX FINGER. (TWO HANDED) THE PINK SHEATH BROKE OFF AND THE NEEDLE SCRAPED HER FINGER. NURSE FOLLOWED UP THROUGH EMPLOYEE HEALTH FOR EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE HYPODERMIC NEEDLE FMI BECTON DICKINSON AND COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *