BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE

    MDR report key: 2003181 · Received February 22, 2011

    Report

    Report Number
    8041187-2011-00003
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT NURSE ATTEMPTED TO LOCK SAFETY SHIELD ON NEEDLE AFTER GIVING AN INJECTION. SHIELD DID NOT LOCK AND FLIPPED BACK CAUSING A NEEDLE STICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD ECLIPSE 3ML SYRINGE W/23G X 1" SHIELDING HYPODERMIC NEEDLE FMI BD NA 9323018

    Patients

    Seq Age Sex Outcome Treatment
    1