BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B-D 60 ML SYRINGE LUER-LOK TIP

    MDR report key: 5979799 · Received September 23, 2016

    Report

    Report Number
    MW5065036
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    B-D
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CHEMOTHERAPY TECH WAS UTILIZING A BD SYRINGE TO WITHDRAW RITUXAN FROM A VIAL AND SHE NOTICED LEAKAGE FROM AROUND THE BLACK PLUNGER. LOT #6182677, EXP (B)(6) 2021 FOR BD 60 ML SYRINGE. TECH HAD TO STOP AND DISCARD RITUXAN TO START COMPOUNDING PROCESS OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626719 B-D 60 ML SYRINGE LUER-LOK TIP 60 ML SYRINGE FMF B-D 309653 6182677

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR