BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD 50ML SYRINGE- LUER LOK TIP

    MDR report key: 10055618 · Received May 13, 2020

    Report

    Report Number
    MW5094483
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    May 11, 2020
    Report Date
    May 11, 2020
    Manufacturer
    BECTON DICKINSON & COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BD 50ML SYRINGE, LOT NUMBER 003159, EXP DATE 01/31/2025, HAS HAD SEVERAL SYRINGES LEAKING FROM THE RUBBER STOPPER INTO THE BARREL OF THE SYRINGE. THESE SYRINGES WERE USED TO PREPARE CHEMOTHERAPY, WHICH COULD HAVE EXPOSED PHARMACY TECHNICIAN TO CHEMOTHERAPY DURING THE PREPARATION PROCESS. TECHNICIAN HAS NOTED 4 TO 5 SYRINGES WITH THE SAME PROBLEM, ALL FROM THE SAME LOT NUMBER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518018 BD 50ML SYRINGE- LUER LOK TIP SYRINGE, PISTON FMF BECTON DICKINSON & COMPANY 003159
    518019 BD 50ML SYRINGE- LUER LOK TIP SYRINGE, PISTON FMF BECTON DICKINSON & COMPANY 0031559
    518020 BD 50ML SYRINGE- LUER LOK TIP SYRINGE, PISTON FMF BECTON DICKINSON & COMPANY 0031559
    518021 BD 50ML SYRINGE- LUER LOK TIP SYRINGE, PISTON FMF BECTON DICKINSON & COMPANY 0031559
    518022 BD 50ML SYRINGE- LUER LOK TIP SYRINGE, PISTON FMF BECTON DICKINSON & COMPANY 0031559

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention