BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G X 8MM BD PEN NEEDLE

    MDR report key: 2334309 · Received November 4, 2011

    Report

    Report Number
    9616656-2011-00033
    Event Type
    Injury
    Date Received
    November 4, 2011
    Date of Event
    September 14, 2011
    Report Date
    November 4, 2011
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ISSUE: NEEDLE BREAK OFF IN USE. TEST/INVESTIGATION: ONE OPEN SAMPLE RECEIVED ATTACHED TO LANTUS PEN DEVICE. ONE SAMPLE FROM LOT: 1062120 CAT: 320631. THE 10X VISUAL INSPECTION AND DHR REVIEW. ELECTRON MICROSCOPE ANALYSIS. RESULTS: THE 10X VISUAL INSPECTION OF RETURNED SAMPLES FOUND NO EVIDENCE OF MFG RELATED ISSUE. ELECTRON MICROSCOPE ANALYSIS CONCLUDED THE "FRACTURE WAS DUCTILE AND WAS DUE TO APPLIED OVERLOAD FORCE." NO RELATED INCIDENTS DURING THE MFR OF LOT: 1062120 BUT BD WILL MONITOR SHOULD A TREND ARISE.

    Description of Event or Problem · 1

    COMPANY REP REPORTED NEEDLE BREAK OFF. THE BROKEN NEEDLE WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G X 8MM BD PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 1062130

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention