BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE SHORT INSULIN PEN NEEDLE

    MDR report key: 4251772 · Received November 6, 2014

    Report

    Report Number
    2243072-2014-00272
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    November 6, 2014
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN QUESTION WAS DISCARDED BY THE HOSPITAL. THE CONSUMER STATES THAT SHE WILL SEND SAMPLES FROM THE SAME BOX. ONCE THE SAMPLES ARE RECEIVED THEY WILL BE EVALUATED ADN UPON COMPLETION OF THE INVESTIGATION , A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTS THAT AS SHE WAS REMOVING THE INNER SHIELD FROM A 31 GAUGE X 8 MM BD ULTRA FINE SHORT INSULIN PEN NEEDLE THE NEEDLE DROPPED ONTO THE FLOOR. THE CONSUMER IS LEGALLY BLIND AND SHE UNKNOWINGLY STEPPED ON THE DROPPED NEEDLE. THE CONSUMER ALSO HAS NEUROPATHY IN HER FEET AND WHEN SHE STEPPED ON THE NEEDLE SHE WAS UNABLE TO FEEL IT AND IT BECAME EMBEDDED IN HER FOOT. THE CONSUMER WAS EVENTUALLY HOSPITALIZED AND REQUIRED TWO DIFFERENT SURGERIES TO REMOVE THE NEEDLE. THE CONSUMER STATES THAT SHE CURRENTLY HAS A BONE INFECTION RELATED TO THE INJURY AND THAT SHE IS ON TWO DIFFERENT IV ANTIBIOTICS FOR THE NEXT 4-6 WEEKS TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716079 BD ULTRA FINE SHORT INSULIN PEN NEEDLE NONE FMI BD 2249240

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention