BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD DISPOSABLE SYRINGE

    MDR report key: 1211583 · Received October 23, 2008

    Report

    Report Number
    1911916-2008-00010
    Event Type
    Injury
    Date Received
    October 23, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COPY OF CUSTOMER AND DISTRIBUTOR RECALL LETTER ENCLOSED.

    Description of Event or Problem · 1

    AFTER TREATING A PATIENT WITH WHAT THE REPORTER BELIEVES WAS A 60ML SYRINGE FROM A LOT RECALLED DUE TO OPEN PACKAGE SEALS, THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD DISPOSABLE SYRINGE 60ML DISPOSABLE SYRINGE FMF BECTON DICKINSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention