BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD AUTOSHIELD PEN NEEDLE

    MDR report key: 1070842 · Received July 3, 2008

    Report

    Report Number
    9610847-2008-00065
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    March 26, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BD MEDICAL - INFUSION THERAPY SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K060007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN DISCARDED: NO PRODUCT RETURN IS ANTICIPATED. LOT NUMBER IS UNKNOWN; UNABLE TO PERFORM DEVICE HISTORY REVIEW. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS. FOLLOW UP CONDUCTED BY SALES TO EVALUATE THE NEED FOR FURTHER IN-SERVICE TRAINING.

    Description of Event or Problem · 1

    RN WENT TO TAKE THE NEEDLE OFF THE INJECTION DEVICE AND GOT A DIRTY NEEDLESTICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD AUTOSHIELD PEN NEEDLE 29 GA X 12.7MM PEN NEEDLE FMI BD MEDICAL - INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other