BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8515055 · Received April 12, 2019

    Report

    Report Number
    MW5085854
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 29, 2019
    Report Date
    March 30, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLACK SMUDGES ON BD INSULIN SYRINGES WITH THE BD ULTRA-FINE NEEDLE. ADDRESS IN BD, (B)(4). NDC/HR# 08290-3284-40 32840; 1/2 UNIT. CAPACITY 3/10 ML / CC; LENGTH 8MM; GAUZE 31G. I PURCHASED THE ABOVE INSULIN SYRINGES FOR MY CAT. MY CAT HAS DIABETES. THIS INSULIN SYRINGE IS USED BY BOTH PEOPLE AND ANIMALS. I NOTICED THAT THE BD INSULIN SYRINGES WITH THE BD ULTRA-FINE NEEDLE HAD BLACK SMUDGES NEAR THE TOP OF THE NEEDLE ON THE INSIDE OF THE SYRINGE. ALL THE NEEDLES IN 2 BOXES HAD BLACK SMUDGES. THE MFR IS TESTING THE NEEDLES, BUT IT IS NOW 1 1/2 MONTHS THAT THE NEEDLES ARE IN THE LAB. I HAVEN'T HEARD ANYTHING. NEITHER THE MFR NOR THE PHARMACY ((B)(6)) WILL GIVE ME A REPLACEMENT OR WILL GIVE MY MONEY BACK. THESE NEEDLES MAY VERY WELL BE UNSAFE AND NEED TO BE RECALLED. MAY BE CONTAMINATED. IF CONTAMINATED, INSULIN WILL BE CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305005 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE NEEDLE SYRINGE PISTON FRN BECTON DICKINSON AND COMPANY NDC/HR# 08290-3284-40
    305006 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE NEEDLE SYRINGE PISTON FRN BECTON DICKINSON AND COMPANY NDC/HR# 08290-3284-40

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR