BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUSELECT 8.0, REPLACEMENT INNER CANNULA, NON-FEN, 50/BX

    MDR report key: 20272284 · Received September 20, 2024

    Report

    Report Number
    9617604-2024-00726
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 21, 2024
    Report Date
    December 23, 2024
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTO
    UDI-DI
    15019517077865
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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

    D9. DATE RETURNED TO MFG: 17-SEP-2024. H6. COMPONENT CODE: UPDATED. INVESTIGATION SUMMARY: ONE (1) RETURNED SAMPLE OF P/N 101/858/080 FROM LOT: 4440315 WAS RECEIVED IN UNUSED CONDITION AND IN ITS ORIGINAL PACKAGING. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AT 12¿ TO 16¿ AND NORMAL CONDITIONS OF ILLUMINATION. PER VISUAL INSPECTION, NO DAMAGE WAS IDENTIFIED IN THE SAMPLE RETURNED. A RING GAUGE TEST WAS PERFORMED ON THE SAMPLE TO VERIFY THE EXTERNAL DIAMETER ¿CLICK FIT OD - OVER BUMPS¿. SAMPLE FAILED THE ¿MINIMUM¿ RING GAUGE TEST. FAILURE MODE REPORTED: ¿A0266 - INNER CANNULA PROBLEM¿ WAS CONFIRMED. THE ROOT CAUSE WAS A SUPPLIER ISSUE, INNER CANNULA PART NUMBER 10001190-001 WAS FOUND TO HAVE A BURR ON THE GATE OF THE CAVITY. SUPPLIER INSPECTION PROCEDURE NOT CLEAR, IT ONLY INCLUDED THE TOOL THAT NEEDED TO BE USED, BUT DID NOT INCLUDE A METHOD/INSPECTION CRITERION. ACTION TAKEN: SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) SNN-00004792 WAS OPENED ON OCTOBER 31 TO THE SUPPLIER OF COMPONENT PART NUMBER P/N 10001190-001 TO ADDRESS THE CLICK FIT OD OUT OF SPEC CONDITION. THE SCAR WAS CLOSED WITH THE FOLLOWING ACTIONS TAKEN: 1. THE TOOL WAS REPAIRED TO ELIMINATE BURR ON THE GATE OF CAVITY. 2. INSPECTION PROCEDURE WAS UPDATED TO ADD DETAILED INSTRUCTIONS FOR THE USE OF THE INSPECTION GAGE AND ADD ACCEPTANCE CRITERIA. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER CANNULA WAS NOT CLICKING INTO PLACE INSIDE THE TRACH AND CAN SLIDE RIGHT OUT. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526053 BLUSELECT 8.0, REPLACEMENT INNER CANNULA, NON-FEN, 50/BX TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4440315 15019517077865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown