BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT

    MDR report key: 8375256 · Received February 27, 2019

    Report

    Report Number
    3012307300-2019-01047
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 3, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    OFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION RESULTS: ONE PORTEX BLUE LINE ULTRA (BLU) TRACHEOSTOMY TUBE WAS RETURNED IN USED CONDITION. VISUAL INSPECTION REVEALED THAT THE INNER CANNULAS HAD SPLIT ACROSS ITS LENGTH. TO VERIFY THAT THE INNER CANNULA DURABILITY, THE TECHNICIAN CARRIED OUT INFORMATIVE TESTING ON RANDOMLY SELECTED INNER CANNULA SAMPLES OF EACH SIZE (6.0MM - 10.0MM, BOTH FENESTRATED AND NON-FENESTRATED VERSIONS) FROM CURRENT BATCHES TO MEASURE THEIR PERFORMANCE USING ESTABLISHED STANDARD TEST METHODS. BASED ON THE RESULTS OF THE TESTING OF THE CURRENT BLU THIN WALL INNER CANNULAS IT WAS DETERMINED THAT THEY WERE SUITABLE FOR THEIR INTENDED FUNCTION. THE INVESTIGATION RESULTS INDICATED THAT THE EVENT WAS MOST LIKELY CAUSED BY EXCESSIVE FORCE USED DURING CLEANING OR DUE TO AN INCORRECT CLEANING TECHNIQUE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY HAD A CANNULA CRACK, REQUIRING REPLACEMENT. THE INCIDENT WAS REPORTED AS BEING RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169475 BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT TRACHEOBRONCHIAL SUCTION CATHETER KIT OFR SMITHS MEDICAL ASD, INC. 3601242

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention