BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE

    MDR report key: 3060371 · Received April 11, 2013

    Report

    Report Number
    2243072-2013-00029
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 PHARMACIST REPORTED THAT THE CUSTOMER HAD A NEEDLE REMAIN IN THE SKIN TO AN UNK AREA OF THE BODY. ON AN UNK DATE, THE CUSTOMER WENT TO THE HOSPITAL AND AN INCISION WAS MADE BUT THE NEEDLE WAS NOT FOUND. THE CUSTOMER THEN WENT HOME AND FOUND THE NEEDLE ON THE FLOOR AT THEIR HOME. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154670 BD ULTRA-FINE PEN NEEDLE-31G ULTRA-FINE III FMI BECTON DICKINSON 2095498

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention