BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 1033823 · Received April 11, 2008

    Report

    Report Number
    1033823
    Event Type
    Malfunction
    Date Received
    April 11, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 7, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE EPIDURAL CATHETER BROKE OFF (SHEARED OFF) AND REMAINED ENTRAPPED IN THE EPIDURAL SPACE WHEN REMOVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX KIT, EPIDURAL CAZ SMITHS MEDICAL ASD, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR