BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT TRACHEOSTOMY TUBE

    MDR report key: 14252089 · Received April 29, 2022

    Report

    Report Number
    3012307300-2022-07215
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 1, 2022
    Report Date
    July 19, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019517076158
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: ONE USED DECONTAMINATED SAMPLE 10009163-004 8MM DEHT BLU SUCTIONAID SUB-ASSY WAS RETURNED FOR INVESTIGATION (SEE PHOTO OF SAMPLE). UNDER VISUAL INSPECTION WE NOTICED THAT INFLATION LINE WAS DETACHED FROM PILOT BALLOON. 10001429-004 INFL. LINE S/ASSY SOFT-SEAL 8MM IS ASSEMBLED IN SMITHS MEDICAL TIJUANA THEREFORE SECONDARY INVESTIGATION OBJECT WAS CREATED WITH PURPOSE TO CAPTURE COMPONENT INVESTIGATION. SIMILAR CUSTOMER COMPLAINTS HAVE BEEN RECENTLY RECEIVED THEREFORE INTERNAL NON-CONFORMITY REPORT NCR-000928 WAS CREATED WITH PURPOSE TO EVALUATE THIS ISSUE. SMITHS MEDICAL TIJUANA SITE CONFIRMED THAT NO MORE PHYSICAL COMPLAINT SAMPLES ARE NEEDED FOR INVESTIGATION THEREFORE SAMPLE IS KEPT IN SMITHS MEDICAL CZECH REPUBLIC. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT.SIMILAR CUSTOMER COMPLAINTS HAVE BEEN RECENTLY RECEIVED THEREFORE INTERNAL NON-CONFORMITY REPORT NCR-000928 WAS CREATED WITH PURPOSE TO EVALUATE THIS ISSUE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE INFLATION LINE GOT DETACHED FROM THE PILOT BALLOON. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98884 PORTEX BLUSELECT TRACHEOSTOMY TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 101/860/080CZ 15019517076158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown