BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIFIX FX

    MDR report key: 530541 · Received June 16, 2004

    Report

    Report Number
    2523676-2004-00046
    Event Type
    Injury
    Date Received
    June 16, 2004
    Date of Event
    May 18, 2004
    Report Date
    June 15, 2004
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: FX CATHETER SHEARED, BUT THE CATHETER WAS BEING USED WITH BD DURASAFE CSE SET, REORDER NUMBER 405139, LOT# 3231873. A FRAGMENT REMAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIFIX FX CUSTOM EPIDURAL ANESTHESIA TRAY CAZ B. BRAUN MEDICAL, INC. CESK EV023745

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other