BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT TRACHEOSTOMY TUBE

    MDR report key: 16308291 · Received February 6, 2023

    Report

    Report Number
    3012307300-2023-00922
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    January 1, 2023
    Report Date
    February 6, 2023
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019517076196
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE USED DECONTAMINATED SAMPLE DEVICE WAS RETURNED FOR INVESTIGATION. UNDER VISUAL INSPECTION, IT WAS OBSERVED THAT THE INFLATION LINE WAS DAMAGED. UNDER MAGNIFYING GLASS, THE DEFECT WAS DETERMINED TO BE A TEAR CAUSING THE REPORTED LEAKAGE. DURING THE MANUFACTURING PROCESS, EACH DEVICE IS INFLATION TESTED. THIS INCLUDES INFLATING EACH DEVICE AND LEAVING FOR A 12 HOUR PERIOD. THIS DEVICE WAS INFLATED AND WAS NOT ABLE TO STAY INFLATED FOR 12 HOURS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS. EXPIRATION DATE AND DEVICE MANUFACTURE DATE: MANUFACTURE DATE ARE UNKNOWN, NO INFORMATION IS AVAILABLE BASED ON REPORTED LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT. LOT NUMBER 3942246 WAS REPORTED, BUT COULD NOT BE VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326820 PORTEX BLUSELECT TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 101/870/060CZ 3942246 15019517076196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown