BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA FENESTRATED INNER CANNULA TRACHEOSTOMY TUBE

    MDR report key: 21882069 · Received April 22, 2025

    Report

    Report Number
    3012307300-2025-04583
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    January 1, 2025
    Report Date
    April 22, 2025
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTO
    UDI-DI
    15019315024047
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN: 3011237704-2025-00016-00. THE DATE OF THAT SUBMISSION WAS 03-FEB-2025. B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION SUMMARY: ONE USED DECONTAMINATED 007/920/275 BLU THIN WALL FENES. INNER CANN. 7.5MM S/ASSY 1/EA WAS RETURNED FOR INVESTIGATION. THE CUSTOMER IS CLAIMING INNER CANNULA DAMAGE WHICH OCCURRED DURING USE. UNDER VISUAL INSPECTION WE NOTICED THAT INNER CANNULA IS CRACKED / DAMAGED AS DESCRIBED BY CUSTOMER. AFFECTED INNER CANNULA IS A DISPOSABLE DEVICE WHICH IS REGULARLY CLEANED BY CUSTOMER AND THEREFORE IT SHALL BE REPLACED BASED ON ITS CONDITION AS DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE). INNER CANNULA WALL THICKNESS DIMENSION HAS DIRECT IMPACT ON INNER CANNULA DURABILITY. THEREFORE, THIS DIMENSION WAS MEASURED AT 0.44MM, 0.46MM, 0.44MM, AND 0.47MM, WITH AN AVERAGE 0.45MM. ALL RESULTS WERE FOUND TO BE WITHIN DRAWING SPECIFICATION. INVESTIGATION RESULTS INDICATES THAT THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE OCCURRED DUE TO EXCESSIVE FORCE USED DURING CLEANING OR INCORRECT CLEANING TECHNIQUE. NO SIGNAL OF CONFIRMED COMPLAINTS IN RELATION WITH THIS ISSUE WAS IDENTIFIED. INNER CANNULA CRACK IS REPORTED RARELY AND IS CONSIDERED TO BE ISOLATED INCIDENT WITHOUT ANY FURTHER ACTION TAKEN FROM ICU MEDICAL (SMITHS MEDICAL). 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 FENESTRATED INNER TUBE FRACTURED ACROSS THE FENESTRATIONS AFTER LIMITED USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239234 PORTEX BLUE LINE ULTRA FENESTRATED INNER CANNULA TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S 4446442 15019315024047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown