BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIC TRACH TUBE

    MDR report key: 742388 · Received December 23, 2004

    Report

    Report Number
    1217052-2004-00093
    Event Type
    Injury
    Date Received
    December 23, 2004
    Report Date
    November 23, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT KEEP THE ACTUAL SAMPLE USED ON THIS PATIENT. THEY DID RETURN A SAMPLE FROM THE LOT THAT THEY THINK THE EVENT OCCURRED WITH. SMITHS MEDICAL ASD, INC. HAS NOT RECEIVED ANY SIMILAR REPORTS ON THIS DEVICE CATALOG NUMBER. AN INITIAL FUNCTION TEST HAS BEEN PERFORMED AND NOTHING WAS OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    DURING USE THE TRACHEOSTOMY TUBE WAS PRETESTED SUCCESSFULLY, HOWEVER, DURING USE TIDAL VOLUME DROPPED AND HAD TO DO AN EMERGENT TUBE REPLACEMENT. THE NEW TUBE WAS PUT IN AND NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIC TRACH TUBE TRACHEOSTOMY TUBE BTO SMITHS MEDICAL ASD, INC. NA K540476

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention