BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE

    MDR report key: 17694429 · Received September 6, 2023

    Report

    Report Number
    3012307300-2023-08737
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    July 1, 2023
    Report Date
    January 8, 2024
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EMAIL IS: (B)(6). D10, H3 AND H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: FOUR SAMPLES WITH LOT 3983562 (IN THEIR ORIGINAL PACKAGES) WERE RECEIVED FOR INVESTIGATION. UNDER VISUAL INSPECTION IT WAS NOTICED THAT THERE ARE PRESENT WHITE PARTICLES ON THE SURFACE OF THE CUFF OF THE DEVICE. THE COMPLAINT WAS CONFIRMED. ROOT CAUSE WAS RELATED TO THE RESIN USED TO MAKE THE DEVICE. THE POWDER WAS FOUND TO BE CAUSED BY RESIN WHICH IS USED FOR CUFF THE BLOW MOLDING PROCESS. THIS RESIN IS A PURCHASED MATERIAL. THE SUPPLIER FOUND THAT A CERTAIN COMPONENT OF THE PLASTICIZER HAD INCREASED TO A LEVEL THAT MADE IT LESS COMPATIBLE WITH PVC AND THEREFORE COULD MIGRATE TO THE SURFACE AS A POWDER OR RESIDUE. WHILE THE COMPONENT LEVEL WAS WITHIN SUPPLIER'S SPECIFICATION OF PLASTICIZER, THE SUPPLIER AGREED THAT THE LEVEL WAS HIGHER THAN IN PAST YEARS. THE PLASTICIZER SPECIFICATION WAS TIGHTENED TO A LEVEL WHICH PREVENTS THIS MIGRATION ISSUE. SUBSEQUENT PRODUCTION WAS SUCCESSFULLY VERIFIED. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME. THIS ISSUE WILL CONTINUE TO BE MONITORED AND FURTHER ACTIONS TAKEN ACCORDINGLY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING TIME OF MANUFACTURE, TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: NO 510K AS PRODUCT NOT SOLD IN US. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING "WHITE PATCHES" WERE SEEN IN THE BALLOON CUFF OF THE TRACHEOSTOMY TUBES. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055955 PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/810/080 3983562

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown