BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE

    MDR report key: 18498652 · Received January 11, 2024

    Report

    Report Number
    3011237704-2024-00013
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    November 1, 2023
    Report Date
    March 20, 2024
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTO
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, DAY IS UNKNOWN. D4: LOT NUMBER, UDI NUMBER, EXPIRATION DATE, AND H4: MANUFACTURE DATE ARE UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. E2 INCORRECT DUE TO SYSTEM LIMITATIONS. H3 OTHER: DEVICE HAS NOT BEEN RETURNED FOR THIS FILE TO DATE. INITIAL REPORTER IS COMPANY SALES ACCOUNT REPRESENTATIVE (NON-HEALTHCARE PROFESSIONAL). 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

    TWO DEVICES WERE RECEIVED FOR INVESTIGATION. DURING VISUAL INSPECTION, NO DAMAGE OR ANOMALIES WERE OBSERVED WITH EITHER DEVICE. EACH DEVICE WAS FUNCTIONALLY TESTED, AND NO AIR LEAKAGE WAS OBSERVED IN EITHER SAMPLE DURING TESTING. NO PRODUCT LOT NUMBER WAS PROVIDED, THEREFORE, NO REVIEW OF MANUFACTURING DEVICE HISTORY RECORDS COULD BE CONDUCTED. BASED ON THE AVAILABLE INFORMATION AND RESULTS OF THE TESTING, THE REPORTED ISSUE COULD NOT BE CONFIRMED AND NO ROOT CAUSE COULD BE FOUND. NO ACTIONS HAVE BEEN TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, WHEN THE CUSTOMER TRIED TO INFLATE THE CUFF, IT DID NOT INFLATE. WHEN THE SALES REPRESENTATIVE TESTED THE RETURNED SAMPLE, THERE APPEARED TO BE NO PROBLEMS. THE EVENT OCCURRED IN NOV-2023. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED. THE LOT NUMBER HAS NOT BEEN REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003237 PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S 101/860/080 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown