BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX PERCUTANEOUS DILATION TRACHEOSTOMY (PDT) KIT, 8MM

    MDR report key: 21037139 · Received December 30, 2024

    Report

    Report Number
    3011237704-2024-00279
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    April 15, 2024
    Report Date
    December 30, 2024
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    BTO
    UDI-DI
    15019315060298
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H4. DEVICE MFG DATE: THE REPORTED LOT# 4362786 COULD NOT BE FOUND FOR THE REPORTED CATALOG# 100/597/080 IN THE ICU MEDICAL SYSTEM; THEREFORE, THE MANUFACTURING DATE COULD NOT BE DETERMINED. INVESTIGATION SUMMARY: NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. 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 BALLOON CUFF ON THE TRACHEOSTOMY TUBE WAS LEAKING. FREQUENT TOP-UP'S OF AIR REQUIRED TO MAINTAIN SEAL OF CUFF. IT WAS REALIZED THE BALLOON CUFF HAD A FAULTY VALVE. WHEN THE VALVE WAS SECURED WITH A SMART-SITE THERE WAS NO FURTHER DEFLATION OF THE BALLOON. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227270 PORTEX PERCUTANEOUS DILATION TRACHEOSTOMY (PDT) KIT, 8MM TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL CZECH REPUBLIC A. S 4362786 15019315060298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown