BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE

    MDR report key: 3152041 · Received March 4, 2009

    Report

    Report Number
    8041187-2009-00010
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Report Date
    March 4, 2009
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINICIAN WENT TO ACTIVATE SAFETY SHIELD WITH FINGER AND THE SAFETY MECHANISM MOVED TO THE SIDE WHICH RESULTED IN A NEEDLE STICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD ECLIPSE 25G X 1" SHIELDING HYPODERMIC NEEDLE FMI BD NA 7170564

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK