BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREVERA BREAST BIOPSY SYSTEM

    MDR report key: 19200933 · Received April 29, 2024

    Report

    Report Number
    19200933
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 19, 2024
    Report Date
    April 24, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KNW
    UDI-DI
    15420045512863
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SETTING UP BREVERA BIOPSY NEEDLE DEVICE FOR BREAST BIOPSY, NOTICIED BLUE CAP WAS MISSING FROM END OF NEEDLE. UNABLE TO PERFORM TESTING WITHOUT CAP. NEEDLE WAS SET ASIDE AND NEW NEEDLE WAS USED FOR PROCEDURE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306511 BREVERA BREAST BIOPSY SYSTEM INSTRUMENT, BIOPSY KNW HOLOGIC, INC. BREVDISP09 24A15RA 15420045512863

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female