BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUSELECT 8.0, REPLACEMENT INNER CANNULA, NON-FEN

    MDR report key: 20135197 · Received September 4, 2024

    Report

    Report Number
    9617604-2024-00682
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    June 28, 2024
    Report Date
    July 25, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTO
    UDI-DI
    15019517077797
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWENTY (20) RETURNED SAMPLES OF P/N 101/856/080 FROM LOT: 4435051 WERE RECEIVED IN UNUSED CONDITION AND IN THEIR ORIGINAL PACKAGING. THE 20 RETURNED SAMPLES WERE VISUALLY INSPECTED AT 12¿ TO 16¿ AND NORMAL CONDITIONS OF ILLUMINATION. PER VISUAL INSPECTION, NO DAMAGE WAS IDENTIFIED IN ANY OF THE FIFTY SAMPLES RETURNED. A RING GAUGE TEST WAS PERFORMED ON THE 20 RETURNED SAMPLES TO VERIFY THE EXTERNAL DIAMETER ¿CLICK FIT OD - OVER BUMPS¿. ALL SAMPLES FAILED THE ¿MINIMUM¿ RING GAUGE TEST. THE CUSTOMER'S INDICATED FAILURE WAS CONFIRMED. A BLUSELECT TRACHEOSTOMY TUBE OF THE SAME SIZE (8MM) AS THE SAMPLE RETURNED BY THE CUSTOMER WAS TAKEN AND THE CANNULA WAS INSERTED TO VERIFY IF THE CANNULA FIT CORRECTLY INTO THE TRACHEOSTOMY TUBE. THE CANNULA WAS NOT CORRECTLY FITTED INTO THE TUBE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Additional Manufacturer Narrative · 0

    H6. CODES: UPDATED. UPDATED INVESTIGATION AND ROOT CAUSE: TWENTY (20) RETURNED SAMPLES OF THE SAME PART AND LOT NUMBER WERE RECEIVED IN UNUSED CONDITIONS AND IN ITS ORIGINAL PACKAGING. VISUAL INSPECTION: THE RETURNED SAMPLES WERE VISUALLY INSPECTED, AND NO DAMAGE WAS IDENTIFIED IN ANY OF THE SAMPLES RETURNED. DIMENSIONAL: RING GAUGE TEST WAS PERFORMED TO VERIFY THE EXTERNAL DIAMETER ¿CLICK FIT OD - OVER BUMPS¿ ACCORDING TO PROCEDURE. RESULTS: ALL SAMPLES FAILED THE ¿MINIMUM¿ RING GAUGE TEST. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS IDENTIFIED AS OUTSIDE DIAMETER (OD) OVER BUMPS OUT OF SPECIFICATION TO FLASH ON SUPPLIER TOOL (CAVITY 2) ACTION TAKEN: SUPPLIER MOLD WAS REPAIRED TO REMOVE BURR ON CAVITY 2. SUPPLIER UPDATED INSPECTION TEST METHOD TO ALIGN WITH ICU MEDICAL METHOD. ICU MEDICAL INSPECTION PROCEDURE RELEASED WITH NEW INSPECTION METHOD ¿CLICK FIT OD - OVER BUMPS¿ TO PERFORM SAMPLING DURING RECEIVING INSPECTION. A RETROSPECTIVE 12-MONTH REVIEW PERIOD (AUG 2023 TO SEP 2024) WAS MADE FOR COMPLAINTS ORIGINATED AND RELATED TO THIS ISSUE AND ONE ADDITIONAL COMPLAINT WAS IDENTIFIED FOR THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER CANNULAS FAILED TO SECURE TO THE TRACH. THE CUSTOMER MENTIONED THAT THIS WAS THE SECOND TIME THEY HAD NOTICED THE ISSUE. THE FIRST WAS APPROXIMATELY A MONTH AGO. THREE BOXES OF 20 WERE INVOLVED IN THE EVENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848301 BLUSELECT 8.0, REPLACEMENT INNER CANNULA, NON-FEN TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4435051 15019517077797

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown