BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 1023726 · Received March 27, 2008

    Report

    Report Number
    1920898-2008-00005
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    November 12, 2007
    Report Date
    March 27, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE. IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNK. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER'S REP INDICATES CONSUMER RECEIVED NEEDLE STICK WHEN REACHING FOR SYRINGES IN POLYBAG. IT WAS CLAIMED THAT THE SHIELDS WERE OFF IN POLYBAG. REP STATED THAT CONSUMER MAY HAVE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN INSULIN SYRINGE FMF BECTON DICKINSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other