BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECTON, DICKINSON & CO. KERRISON

    MDR report key: 11107969 · Received December 31, 2020

    Report

    Report Number
    MW5098617
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    December 16, 2020
    Report Date
    December 29, 2020
    Manufacturer
    BECTON, DICKINSON & CO. / CAREFUSION 2200, INC.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 3MM Z-COAT KERRISON TIP BROKE ROUTINE/PROPER USE. PER SCRUB RN, BROKEN PIECE RETRIEVED FROM SURGICAL INCISION FIELD AND BROKEN PIECE FITS EXACTLY WITH KERRISON INSTRUMENT. REMOVED FROM BACK TABLE. BROKEN INSTRUMENT LABELED AND SENT DOWN TO SPD ON CASE CART. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563866 BECTON, DICKINSON & CO. KERRISON RONGEUR, MANUAL HAE BECTON, DICKINSON & CO. / CAREFUSION 2200, INC. 4251-83T

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR