BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL NEEDLE WITH CENTIMETER DEPTH MARKINGS FROM AMNIOCENTE

    MDR report key: 2103472 · Received May 10, 2011

    Report

    Report Number
    2103472
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE FROM THE STERILE AMNIOCENTESIS TRAY WAS INSERTED UNDER CONTINUOUS ULTRASOUND GUIDANCE AND DIRECTED INTO THE AMNIOTIC SAC. THE CORRECT POSITION WAS CONFIRMED BY ULTRASOUND EXAMINATION. ONLY A SMALL AMOUNT OF AMNIOTIC FLUID WAS RETRIEVABLE AND A SIGNIFICANT AMOUNT OF PRESSURE WAS NECESSARY TO REMOVE THAT. THE NEEDLE WAS WITHDRAWN AND ANOTHER 20 GAUGE NEEDLE WAS INSERTED IN THE SAME LOCATION WITHOUT ANY DIFFICULTIES OR COMPLICATIONS. THE AMNIOTIC FLUID WAS OBTAINED WITHOUT ANY DIFFICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL NEEDLE WITH CENTIMETER DEPTH MARKINGS FROM AMNIOCENTE SPINAL NEEDLE CAZ CAREFUSION * L1A137

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR PRENATAL MEDICATION