BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 4202005 · Received August 27, 2014

    Report

    Report Number
    4202005
    Event Type
    Death
    Date Received
    August 27, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE USED THE 18 GAUGE NEEDLE TO WITHDRAW MEDICATION FROM A VIAL WITH A RUBBER TOP. THE NEEDLE RIPPED A PORTION OF THE RUBBER TOP AND IT WENT INTO THE SYRINGE ALONG WITH THE MEDICATION. THE NURSE SAW IT AND DID NOT ADMINISTER THE MEDICATION. THIS RUBBER PORTION COULD HAVE GONE TO ANY OF THE PATIENT'S MAJOR ORGANS, INCLUDING THE BRAIN AND KILLED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522834 * NEEDLE FMI BECTON DICKINSON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death| O| R