BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYRINGES 60ML

    MDR report key: 6154472 · Received December 6, 2016

    Report

    Report Number
    MW5066580
    Event Type
    Other
    Date Received
    December 6, 2016
    Report Date
    September 2, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FLUID IS GETTING BEYOND THE ENTIRE BLACK RUBBER OF THE BD IV SYRINGES OF MANY DIFFERENT SIZES. WE HAVE BEEN ACTIVELY REPORTING THIS TO BD SINCE 2016. SOME OF THE FEEDBACK FROM THE QUALITY SYSTEMS SPECIALIST AT BD CONFIRMED THE LEAKING AND HAS INDICATED THAT THERE IS A PROJECT TO ADDRESS THE LEAKAGE ISSUES WHICH IS ASSOCIATED WITH THE BARREL DESIGN. SYRINGES SIZES WE HAVE REPORTED TO HAVE LEAKAGE IS 60 ML, 10 ML, 30 ML, 20 ML, AND 5 ML. BD HAS INFORMED US THAT IF THE FLUID GETS BEYOND THE FIRST PART OF THE BLACK RUBBER PLUNGER, THE MEDICATION IS NOT COMPROMISED BUT IF IT GOES BEYOND THE ENTIRE BLACK RUBBER, THE STERILITY IS BREACHED. OUR STAFF SAVE THE SYRINGES AND REPORT THE LOT NUMBER TO ME WHEN THEY SEE IT. I'M UNSURE HOW MANY GO UNDETECTED. I'M REPORTING TO MAKE OTHERS AWARE THAT A STERILITY BREACH MAY GO UNDETECTED. I'TS DIFFICULT TO SEE WITH THE BARE NAKED EYE. MEDICATION NOT ADMINISTERED TO OR USED BY THE PATIENT. PATIENT COUNSELLING PROVIDED: IS UNKNOWN. (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800983 SYRINGES 60ML SYRINGES 60ML FMF BECTON DICKINSON AND CO.
    800984 SYRINGES 10ML SYRINGES 10ML FMF BECTON DICKINSON AND CO.
    800985 SYRINGES 30ML SYRINGES 30ML FMF BECTON DICKINSON AND CO.
    800986 SYRINGES 20ML SYRINGES 20ML FMF BECTON DICKINSON AND CO.
    800987 SYRINGES 5ML SYRINGES 5ML FMF BECTON DICKINSON AND CO.

    Patients

    Seq Age Sex Outcome Treatment
    1