BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPIDURAL MINIPACK 16G SYSTEM 1

    MDR report key: 625936 · Received August 11, 2005

    Report

    Report Number
    1217052-2005-00073
    Event Type
    Other
    Date Received
    August 11, 2005
    Date of Event
    June 22, 2005
    Report Date
    July 22, 2005
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD
    Product Code
    BSO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SMITHS MEDICAL INTERNATIONAL LTD. HAS BEEN NOTIFIED OF AN INCIDENT WHEN REMOVING AN EPIDURAL CATHETER, THE TIP (2CM) BROKE OFF AND REMAINED SUBCUTANEOUS. EVENT WAS CONFIRMED ON CT SCAN. NO ADVERSE OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL MINIPACK 16G SYSTEM 1 KIT, CONDUCTIVE ANESTHETIC BSO SMITHS MEDICAL INTERNATIONAL LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other