BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECTON DICKINSON & CO

    MDR report key: 371997 · Received January 11, 2002

    Report

    Report Number
    MW1023844
    Event Type
    Malfunction
    Date Received
    January 11, 2002
    Date of Event
    June 5, 2001
    Report Date
    January 11, 2002
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO SYRINGES WERE RETURNED TO STOCKROOM IN 6/01. BOTH HAVE FOREIGN MATTER AND WERE DISCOVERED AS PACKAGES WERE OPENED. NEITHER PRODUCT WAS USED. HOSP HAD HELD THEM WAITING FOR NEXT VISIT BY REP AND SINCE IT DIDN'T HAVE VISIT, HOSP DECIDED TO MAIL IN TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECTON DICKINSON & CO SYRINGES FMF BECTON DICKINSON AND CO. UNK 106831013
    2 BECTON DICKINSON & CO SYRINGES FMF BECTON DICKINSON AND CO. UNK 012987207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other