BEUDAMED
    FDA Adverse Event Summary report: N

    BD PROBETEC ET

    MDR report key: 397715 · Received May 30, 2002

    Report

    Report Number
    MW1025154
    Date Received
    May 30, 2002
    Date of Event
    May 24, 2002
    Report Date
    May 30, 2002
    Manufacturer
    BECTON DICKINSON AND CO
    Product Code
    LIO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDICAL ASSISTANT NOTICED A HUMAN HAIR INSIDE A SEALED STERILE "CULTURETTE DIRECT" PACKAGE BD PROBETEC ET (REF440476). UPON FURTHER INSPECTION, SEVERAL MORE PACKAGES WERE FOUND WITH FOREIGN BODIES INSIDE THE SEALED PACKAGE. RPTR HAS REMOVED AND SAVED FIVE SUCH DEFECTIVE PACKAGES IN LOT #N1 FC220 EXP 5/16/03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PROBETEC ET CULTURETTE DIRECT LIO BECTON DICKINSON AND CO REF 440476 N1 FC220

    Patients

    Seq Age Sex Outcome Treatment
    1 *