BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE

    MDR report key: 1901493 · Received November 9, 2010

    Report

    Report Number
    8041187-2010-00010
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY USER. THE 31 SEALED, UNUSED DEVICES THAT WERE AVAILABLE EXHIBITED NO MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    WHEN ACTIVATING THE SAFETY MECHANISM, THE SAFETY SHIELD BROKE WHICH RESULTED IN A NEEDLE STICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD ECLIPSE 25G X 5/8" SHIELDING HYPODERMIC NEEDLE FMI BD NA 9109322

    Patients

    Seq Age Sex Outcome Treatment
    1