BEUDAMED
    FDA Adverse Event Injury Summary report: N

    29G PEN NEEDLE

    MDR report key: 1050179 · Received May 23, 2008

    Report

    Report Number
    9616656-2008-00004
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR THE LOT REPORTED. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED USED PEN NEEDLE FOR INJECTION AND CANNULA BROKE OFF IN HER LEFT ABDOMEN AREA. CONSUMER DID SEEK MEDICAL ATTENTION AND RECEIVED TWO (2) STITCHES AND HAD CANNULA SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 29G PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 7092823

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention