BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD

    MDR report key: 2285955 · Received September 28, 2011

    Report

    Report Number
    2285955
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 28, 2011
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A BECTON DICKINSON AND COMPANY (BD) 1 ML SYRINGE WAS FOUND TO HAVE DEBRIS. SYRINGE WAS NOT OPENED OR USED. THE DEBRIS WAS FOUND IN THE CAVITY OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD GENERAL USE SYRINGE FMF BECTON DICKINSON AND COMPANY 1 ML *

    Patients

    Seq Age Sex Outcome Treatment
    1 *