BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 495791 · Received November 6, 2003

    Report

    Report Number
    2183911-2003-00002
    Event Type
    Other
    Date Received
    November 6, 2003
    Date of Event
    October 27, 2003
    Report Date
    October 30, 2003
    Manufacturer
    B/BRAUN MEDICAL INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN EPIDUROSCOPY PROCEDURE AT A MEDICAL CENTER A PHYSICIAN WAS USING A CLARUS MEDICAL MODEL 2160 SPINESCOPE AND A 2160-901 ACCESS KIT. DURING THE PROCEDURE THE 10 FRENCH INTRODUCER FROM THE ACCESS KIT BROKE. ABOUT 5 CM OF THE INTRODUCER REMAINED IN THE PATIENT. THIS IS THE FIRST TIME SUCH AN EVENT HAS BEEN REPORTED TO CLARUS MEDICAL. THE REMAINING SECTION OF THE INTRODUCER WAS RETURNED TO CLARUS AND EXAMINED. AN EQUIVALENT DEVICE WAS REVIEWED AND TESTED. THE FAILURE MODE COULD NOT BE DUPLICATED. NO DEFECTS COULD BE FOUND IN EITHER INTRODUCER.

    Description of Event or Problem · 1

    THE FAILURE MODE COULD NOT BE DUPLICATED. NO DEFECTS COULD BE FOUND IN EITHER INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PERCUTANEOUS CATHETER INTRODUCER SPECIAL KIT DYB B/BRAUN MEDICAL INC. 2160-901 60271863

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other