BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE

    MDR report key: 2080022 · Received April 6, 2011

    Report

    Report Number
    8041187-2011-00005
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SINCE CONVERTING FROM NON SAFETY TO SAFETY ON THEIR PROCEDURE OF DRAWING UMBILICAL CORD BLOOD GASES, THEY HAVE HAD 6 NEEDLE STICKS. THEIR SLIP TIP SYRINGE BROKE - THEY HAVE TO USE ARTERIAL BLOOD SAMPLE SYRINGE 1 ML AND WHEN PUTTING THE NEEDLE ONTO THE SYRINGE THE TIP OF THE SYRINGE BREAKS OFF. ALSO NURSES HAVE STUCK THEMSELVES BECAUSE OF THE "FLIMSY" NEEDLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1