BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEN NEEDLE 29 G X1 2.7 MM

    MDR report key: 5347606 · Received January 6, 2016

    Report

    Report Number
    9616656-2016-00001
    Event Type
    Injury
    Date Received
    January 6, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 14, 2015
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4043466. AS THERE WAS NO ACTUAL RETURNED SAMPLE FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. IF A SAMPLE IS RETURNED FOR EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS A REPORTED THAT A PATIENT WHO HAD BEEN USING BD PEN NEEDLES FOR MANY YEARS HAD A NEEDLE BREAK OFF IN THE INJECTION SITE WHEN HE WAS REMOVING THE DEVICE. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT AND HAD THE NEEDLE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5829 BD PEN NEEDLE 29 G X1 2.7 MM PEN NEEDLE FMI BECTON DICKINSON AND CO. 4043466

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention