BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML LEUR LOK SYRINGE

    MDR report key: 6025412 · Received October 11, 2016

    Report

    Report Number
    MW5065347
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    BECTON DICKSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PHARMACIST WAS PREPARING CHEMOTHERAPY (CYTOTOXAN) FOR A PATIENT USING A 60ML BD SYRINGE AND NOTICED THAT THE SYRINGE WAS LEAKING FROM THE BLACK RUBBER STOPPER. THE PRODUCT INFORMATION IS: BD 60ML SYRINGE LEUR-LOK TIP REF (B)(4), LOT 6182690, EXP 06/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670339 BD 60ML LEUR LOK SYRINGE BD 60ML LEUR LOK SYRINGE FMF BECTON DICKSON 309653 6182690

    Patients

    Seq Age Sex Outcome Treatment
    1