BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN PEN NEEDLE 31G X 8MM

    MDR report key: 4452620 · Received January 20, 2015

    Report

    Report Number
    2243072-2015-00010
    Event Type
    Injury
    Date Received
    January 20, 2015
    Report Date
    January 21, 2015
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 4232210. CONCLUSIONS: WITHOUT A SAMPLE AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE INCIDENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD INSULIN PEN NEEDLE, THE NEEDLE DETACHED FROM THE HUB AND REMAINED INSIDE THE PATIENT'S ARM. THE PATIENT RECEIVED AN X-RAY WHICH LOCATED THE NEEDLE AND SURGERY UNDER LOCAL ANESTHESIA IS PLANNED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44513 BD INSULIN PEN NEEDLE 31G X 8MM INSULIN PEN NEEDLE FMI BECTON DICKINSON 4232210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention