BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE 31G X 8MM INSULIN PEN NEEDLE

    MDR report key: 3854905 · Received May 28, 2014

    Report

    Report Number
    2243072-2014-00109
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A PREPAID MAILING LABEL AND SHIPPING TUBE HAVE BEEN SENT FOR RETURN OF THE SAMPLES. IF THE SAMPLES ARE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION, (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER HAS HAD TWO NEEDLES BREAK OFF DURING INJECTION DURING THE PAST MONTH. THE CONSUMER IS DIABETIC AND REQUIRES FIVE INJECTIONS PER DAY TO CONTROL HIS DIABETES. HE DOES NOT REUSE THE NEEDLES. ONE NEEDLE BROKE OFF IN HIS ARM AND THE DOCTOR ADVISED THE NEEDLE WOULD LIKELY WORK ITS WAY OUT ON ITS OWN. THE SECOND NEEDLE BROKE OFF IN THE CONSUMER'S STOMACH. X-RAYS WERE TAKEN AND THE NEEDLES WERE CONFIRMED TO BE IN THE ARM AND THE ABDOMEN. THE CONSUMER VISITED THE SURGEON, WHO SURGICALLY REMOVED THE NEEDLE FROM THE CONSUMER'S STOMACH. THE NEEDLE IN THE ARM WAS LEFT ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315064 BD ULTRA-FINE 31G X 8MM INSULIN PEN NEEDLE PEN NEEDLE, 31G X 8MM FMI BD 3277076

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention