BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE, LUER-LOK TIP

    MDR report key: 8811495 · Received July 19, 2019

    Report

    Report Number
    MW5088267
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    July 2, 2019
    Report Date
    July 15, 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

    SEVERAL BD 10ML SYRINGES WITH LUER-LOK TIPS IN THREE BULK STERILE CONVENIENCE PAKS WERE FOUND WITH BLACK CONTAMINANT ON THE OUTSIDE OF THE SYRINGES. THE BLACK SUBSTANCE EASILY TRANSFERS OFF OF THE SYRINGE. THE LOT # 8211647 WAS THE SAME LOT NUMBER FOR ANOTHER MEDWATCH FILED ON MAY 2019. REF: MW5086394 AND MW5086204.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600181 BD 10ML SYRINGE, LUER-LOK TIP SYRINGE, PISTON FMF BECTON DICKINSON AND COMPANY 8211647
    600182 BD 10ML SYRINGE, LUER-LOK TIP SYRINGE, PISTON FMF BECTON DICKINSON AND COMPANY 8211647
    600183 BD 10ML SYRINGE, LUER-LOK TIP SYRINGE, PISTON FMF BECTON DICKINSON AND COMPANY 8211647

    Patients

    Seq Age Sex Outcome Treatment
    1