BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECTON, DICKINSON AND COMPANY

    MDR report key: 9947884 · Received April 10, 2020

    Report

    Report Number
    9947884
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 24, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NYICU (NURSERY INTENSIVE CARE UNIT) RN NOTED LEAKING AT BUFF CAP WHERE 3 ML SYRINGE CONNECTED [TO AN INFUSION PUMP] FOR INFUSION ON A PREEMIE (PREMATURE) INFANT. ANTIBIOTIC WAS CONTAINED INSIDE A BD 3 ML SYRINGE. THIS REPORT IS BEING MADE FOR TRACKING PURPOSES DUE TO THIS CONTINUING ISSUE. WE DO NOT HAVE THE SERIAL OR MODEL NUMBER AS THE SYRINGES ARE PREVIOUSLY FILLED IN PHARMACY. COMPANY IS AWARE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412446 BECTON, DICKINSON AND COMPANY SYRINGE, PISTON FMF BECTON, DICKINSON AND COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1