BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM MINI PEN NEEDLE

    MDR report key: 808400 · Received January 22, 2007

    Report

    Report Number
    9616656-2007-00003
    Event Type
    Injury
    Date Received
    January 22, 2007
    Date of Event
    December 29, 2006
    Report Date
    January 19, 2007
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED BY THE CONSUMER. NO PRODUCT RETURN IS ANTICIPATED. BATCH HISTORY REVIEW (6032022) YIELDED NO ANOMALIES WHICH WOULD HAVE CONTRIBUTED TO THE BREAKOFF OR PULLOUT. IN PREVIOUS COMPLAINTS OF THIS NATURE, EXAMINATION OF THE RETURNED PRODUCT REVEALED THAT THE CAUSE OF THE BREAK WAS DUCTILE FRACTURE, WHICH OCCURS AS A RESULT OF BENDING AND RESTRAIGHTENING OF THE NEEDLE. COMPLAINT HISTORY CHECK RUN ON THIS LOT YIELDED 2 OTHER COMPLAINTS UNRELATED TO THIS EVENT. CANNOT CONFIRM AS A MANUFACTURING DEFECT. NO FURTHER ACTION IS REQUIRED, WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    CONSUMER REPORTS NEEDLE BREAKOFF WHILE INJECTING IN HER STOMACH. HAD TO GO TO THE ER IN A CRITICAL CARE FACILITY AND HAD A NURSE REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM MINI PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 6032022

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention