BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION TRU-CUT BIOPSY NEEDLE

    MDR report key: 9823496 · Received March 11, 2020

    Report

    Report Number
    MW5093681
    Event Type
    Injury
    Date Received
    March 11, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 10, 2020
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD WAS PERFORMING A BREAST BIOPSY USING CAREFUSION TRU-CUT BIOPSY NEEDLE 14 G X 15 CM. MD SAID HE FELT HE WAS "NOT ABLE TO CONTROL" THE BIOPSY NEEDLE. THIS RESULTED IN A PUNCTURE WOUND PENETRATING INTO THE BODY CAVITY WITH PERICARDIAL EFFUSION AND TAMPONADE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283613 CAREFUSION TRU-CUT BIOPSY NEEDLE INSTRUMENT, BIOPSY KNW CAREFUSION 2200, INC. 2N2704X 0000960950

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening