BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA SYRINGE 3ML 25G 1 (0.5X 25MM)

    MDR report key: 1230134 · Received November 12, 2008

    Report

    Report Number
    MW5008981
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN ASPIRATING FROM STERILE VIAL THIS SYRINGE HAS LEAKED MEDICATION DOWN THE PLUNGER ONTO THE HAND OF THE NURSE ON TWO SEPARATE OCCASIONS: THESE OCCURRENCES HAPPENED WITH TWO SEPARATE SYRINGES WITH TWO DIFFERENT NURSES DRAWING UP MEDICATION. THIS LEAK IS POTENTIALLY DANGEROUS TO THE NURSE WHO MAY GET A MEDICATION ON HER HANDS THAT SHE IS ALLERGIC TO, FOR INSTANCE, PENICILLIN. THIS LEAK IS DANGEROUS AS THE STERILITY OF THE ASPIRATED MEDICATION IS COMPROMISED ONCE THE FLUID LEAKS INDICATING THE STERILE COMPARTMENT IN THE SYRINGE IS OPENED. THIS LEAK IS DANGEROUS AS THE CORRECT DOSE COULD BE COMPROMISED. THE IDENTIFIERS ON THE LABEL ARE STAMPED: NO HARM TO PATIENT, LEAKING SYRINGES THROWN OUT - NOT USED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INTEGRA SYRINGE 3ML 25G 1 (0.5X 25MM) RETRACTING 3 CC STERILE SYRINGE FMF BECTON DICKINSON AND COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1