BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLU-SELECT SUCTIONAID TRACHEOSTOMY TUBE, CUFFED

    MDR report key: 18897690 · Received March 13, 2024

    Report

    Report Number
    3011237704-2024-00059
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 13, 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. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. D4. LOT NUMBER, EXPIRATION DATE, UDI, AND H4. MANUFACTURE DATE ARE UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION SUMMARY: ONE USED DECONTAMINATED SAMPLE WAS RETURNED FOR INVESTIGATION. UNDER VISUAL INSPECTION IT WAS FOUND THAT THE INFLATION LINE WAS DETACHED FROM THE PILOT BALLOON, CONFIRMING THE CUSTOMER'S INDICATED FAILURE. THIS ISSUE WAS ESCALATED TO CAPA-000905 AND THE OCCURRENCE IS BEING MONITORED VIA TND-00138. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PILOT BALLOON HAD COME LOOSE FROM THE INFLATION LINE JOINT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018567 PORTEX BLU-SELECT SUCTIONAID TRACHEOSTOMY TUBE, CUFFED TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown