BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAXIAL ACHIEVE

    MDR report key: 9426203 · Received December 5, 2019

    Report

    Report Number
    MW5091481
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 3, 2019
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING A COAXIAL ACHIEVE 14GX 11CM BIOPSY DEVICE FOR A BREAST BIOPSY THE RADIOLOGIST ENGAGED THE NEEDLE TO TAKE THE SAMPLE. THE DEVICE FIRED AND WAS PULLED OUT OF THE PATIENT BUT THE DEVICE WOULDN¿T OPEN BACK UP TO OBTAIN THE SAMPLE. THAT DEVICE WAS REMOVED AND A NEW DEVICE WAS USED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215296 COAXIAL ACHIEVE INSTRUMENT, BIOPSY KNW CAREFUSION 2200, INC. 0001298619

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention