BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA CUFFED FEN TRACHEOSTOMY TUBE KIT W/ INNER CANNULA

    MDR report key: 21293784 · Received February 3, 2025

    Report

    Report Number
    3011237704-2025-00015
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    March 4, 2024
    Report Date
    March 6, 2025
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTO
    UDI-DI
    15019315028182
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. H4. DEVICE MFG DATE: THE REPORTED LOT# 4246109 WAS NOT FOUND FOR THE REPORTED CATALOG# 100/812/070 IN THE SYSTEM; THEREFORE, THE MANUFACTURING DATE COULD NOT BE CONFIRMED. 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

    NO DEVICE WAS RECEIVED FOR INVESTIGATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE REPORTED COMPLAINT. IF WE RECEIVE THE DEVICE, WE WILL REOPEN THE INVESTIGATION FOR FURTHER EVALUATIONS. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DIAMETER OF THE SUB CANNULA WAS NOT COMPATIBLE WITH THICK SECRETIONS, FOUND AT THE MARK AT 7.0 OF THE TRACHEOSTOMY TUBE. THE EVENT OCCURRED IN THE CTI/UTI AND THE PATIENT WAS IN REHABILITATION. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389225 PORTEX BLUE LINE ULTRA CUFFED FEN TRACHEOSTOMY TUBE KIT W/ INNER CANNULA TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S 4246109 15019315028182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown