BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE

    MDR report key: 18484045 · Received January 10, 2024

    Report

    Report Number
    3011237704-2024-00008
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    November 1, 2023
    Report Date
    February 8, 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

    H3 AND H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: TWO DECONTAMINATED SAMPLES WERE RECEIVED FOR INVESTIGATION. UNDER VISUAL INSPECTION THE SAMPLES APPEARED TO BE IN GOOD CONDITION. FUNCTIONAL TESTING FOUND THAT AFTER 12 HOURS THE CUFFS WERE STILL FULLY INFLATED. BASED ON RESULTS OF TESTING THE REPORTED FAILURE WAS NOT OBSERVED OR CONFIRMED. NO TREND OF SIMILAR CUSTOMER COMPLAINTS WAS IDENTIFIED. NO DEVICE HISTORY REPORT (DHR) REVIEW COULD BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. NO ACTION TAKEN.

    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. 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

    ADDITIONAL INFORMATION: B5B5 - NUMBER OF INVOLVED DEVICES.

    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. TWO DEVICES WERE REPORTED TO BE INVOLVED. THE LOT NUMBERS HAVE NOT BEEN REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED CLARIFYING THAT ONLY ONE DEVICE WAS FAULTY FOR PATIENT IDENTIFIED AS (B)(6) IN THE PREVIOUS REPORT 3011237704-2024-00008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031967 PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown