BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE 32GX4MM

    MDR report key: 5944779 · Received September 12, 2016

    Report

    Report Number
    9616656-2016-00056
    Event Type
    Injury
    Date Received
    September 12, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 11, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEALED AND INTACT SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION ON 30 OF THE RETURNED UNITS REVEALED NO ISSUES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5230036. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES AND BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE 32GX4MM BROKE OFF DURING AN INJECTION AND REMAINED IN A PATIENT'S INJECTION SITE (ABDOMEN). A SMALL SURGERY WAS PERFORMED AND THE BROKEN NEEDLE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593962 BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE 32GX4MM INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 5230036

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention