BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD IV SYRINGES 5 ML

    MDR report key: 5935389 · Received September 2, 2016

    Report

    Report Number
    MW5064592
    Event Type
    Other
    Date Received
    September 2, 2016
    Date of Event
    February 1, 2016
    Report Date
    September 2, 2016
    Manufacturer
    BD
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    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 (B)(6) 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 START SAVE THE SYRINGE AND REPORT THE LOT NUMBER TO ME WHEN THEY SEE IT. I'M SURE HOW MANY GO UNDETECTED. INCIDENT REPORTS THAT I HAVE SUBMITTED AND RECEIVED CONFIRMATION LETTERS FROM BD DATE FROM FEBRUARY 2016 THROUGH JULY ALTHOUGH I CONTINUE TO HAVE MANY MORE SYRINGES TO REPORT. LOT NUMBERS THAT WE HAVE REPORTED SO FAR ARE 5238760, 5153859, 6081712, 6111571, 6146533. MANY OF THE SYRINGES WE USE COME IN THE BULK CONVENIENCE PACKS. WE MANUALLY DRAW ALL OF OUR SYRINGES. WE ARE NOT USING A ROBOT. FOR THE PRODUCT DETAILS IN SUBSEQUENT SECTION TO FOLLOW. I ONLY INCLUDED THE PRODUCT ID FOR THE 5 ML, SYRINGES EVEN THOUGH OTHERS ARE AFFECTED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577761 BD IV SYRINGES 5 ML IV SYRINGE LUER-LOK TIP FMF BD 6146533
    577762 BD IV SYRINGES 20 ML IV SYRINGE LUER-LOK TIP FMF BD 6111571
    577763 BD IV SYRINGES 30 ML IV SYRINGE LUER-LOK TIP FMF BD 6081712
    577764 BD IV SYRINGES 10 ML IV SYRINGE LUER-LOK TIP FMF BD 5153859
    577765 BD IV SYRINGES 60 ML IV SYRINGE LUER-LOK TIP FMF BD 5238760

    Patients

    Seq Age Sex Outcome Treatment
    1