BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE

    MDR report key: 3060390 · Received April 11, 2013

    Report

    Report Number
    2243072-2013-00030
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER DECLINED TO GIVE ANY CONTACT INFO. NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED.

    Description of Event or Problem · 1

    ON AN UNK DATE, THE CONSUMER REPORTED THAT THE NEEDLE BROKE AND WENT TO THE EMERGENCY ROOM AND RECEIVED AN X-RAY TO IDENTIFY WHERE THE NEEDLE WAS. THE NEEDLE WAS NOT IDENTIFIED AND POSSIBLY FELL ON THE FLOOR. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155334 BD ULTRA-FINE PEN NEEDLE-31G ULTRA-FINE III FMI BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention