BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3820092 · Received May 12, 2014

    Report

    Report Number
    3820092
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BECTON DICKINSON & CO
    Product Code
    GDM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    SPINAL NEEDLE WAS BEING USED TO PERFORM A PLACENTAL BIOPSY ON PATIENT. WHEN IT WAS TIME TO TAKE THE NEEDLE OUT, IT COULD NOT BE REMOVED. THE SONOGRAPHER ASSISTING THE PHYSICIANS ATTEMPTED TO HELP AND THEN THE NURSE ASSISTING PUSHED DOWN ON THE PATIENT'S SKIN SURROUNDING THE NEEDLE AND IT WAS REMOVED. THE NEEDLE WAS INSPECTED FOR ANY ABNORMALITIES AND NONE WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284840 * NEEDLE GDM BECTON DICKINSON & CO * 3282272

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR