BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE / LUER-LOK TIP

    MDR report key: 8555665 · Received April 25, 2019

    Report

    Report Number
    MW5086204
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 24, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BD 10ML SYRINGE WITH LUER-LOK TIP LOT # 8211647 WAS FOUND WITH EXTRA PLASTIC AT HANDLE OF PLUNGER. IT LOOKED DIRTY AND IT WAS REMOVED AND ALL OF THE SYRINGES IN THE TRAY WERE DISCARDED (WERE NOT USED FOR COMPOUNDING STERILE PRODUCTS). THIS IS THE 4TH TIME WE HAVE FOUND DIRTY BROWN OR BLACK STAINING ON THESE SYRINGES, BUT THE FIRST TIME THERE WAS EXTRA PLASTIC PRESENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343453 BD 10ML SYRINGE / LUER-LOK TIP SYRINGE, PISTON FMF BECTON DICKINSON AND COMPANY 8211647

    Patients

    Seq Age Sex Outcome Treatment
    1