BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE 31G SHORT INSULIN PEN NEEDLE

    MDR report key: 3800296 · Received May 2, 2014

    Report

    Report Number
    2243072-2014-00078
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED, AND THEREFORE NOT AVAILABLE FOR EVAL. WITHOUT A SAMPLE, A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS A LOT NUMBER FOR THIS INCIDENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT A BD NEEDLE BROKE OFF IN HER STOMACH WHILE USING HUMALOG. HER HUSBAND MAY HAVE PULLED THE NEEDLE OUT, BUT THE CONSUMER STILL WENT TO AN URGENT CARE FACILITY. THE DOCTOR CUT A SMALL SLIT IN THE CONSUMER'S BELLY TO SEE IF THE NEEDLE WAS THERE AND NOTHING WAS FOUND. AN X-RAY WAS PERFORMED AND THE NEEDLE WAS NOT FOUND. NO FUTURE FOLLOW-UP FROM THE DOCTOR WAS SUGGESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263952 BD ULTRA FINE 31G SHORT INSULIN PEN NEEDLE PEN NEEDLE, 31G X 8MM FMI BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention