BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUSELECT TRACHEOSTOMY TUBE

    MDR report key: 19651201 · Received July 1, 2024

    Report

    Report Number
    3011237704-2024-00133
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 4, 2024
    Report Date
    August 8, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    BTO
    UDI-DI
    15019315103636
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: ONE USED DECONTAMINATED SAMPLE 007/910/790 BLU FENES. TRACHY TUBE 9.0MM S/ASSY WAS RETURNED FOR INVESTIGATION WITHOUT ITS ORIGINAL PACKAGING. UNDER VISUAL INSPECTION THE SAMPLE APPEARED TO BE IN GOOD CONDITION. DURING MANUFACTURING PROCESS, THE DEVICES ARE 100% INFLATION TESTED, WHICH INCLUDES INFLATING EACH DEVICE CUFF AND LEAVING FOR A 12-HOUR PERIOD. REDUCTIONS IN PRESSURE OVER THIS TIME ARE CONSIDERED A FAILURE AND THE DEVICE WOULD BE REJECTED. THE INFLATION TEST WAS REPEATED ON THE RECEIVED SAMPLE. IT WAS FOUND THAT IT IS DIFFICULT TO INFLATE THE CUFF, THE CUFF LEAKS. WE INFLATED CUFF BY A SYRINGE FILLED WITH AIR AND WE PUT RETURNED DEVICE UNDER WATER. AIR LEAK WAS DETECTED FROM THE CUFF ¿ A HOLE IS VISIBLE. DUE TO FACT THAT CUFF LEAK WAS NOT OBSERVED PRIOR USE IT IS THE MOST PROBABLE THAT REPORTED FAILURE OCCURRED DURING TRACHEOSTOMY PROCEDURE OR DURING USE DUE TO CONTACT WITH A SHARP EDGE. NO TREND OF SIMILAR CUSTOMER COMPLAINTS WAS IDENTIFIED. 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 CANNULA OF THE TRACHEOSTOMY TUBE WAS PLACED ON A PATIENT. AFTER INSTALLATION, THE BALLOON WAS NOT ABLE TO BE INFLATED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571776 PORTEX BLUSELECT TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC 3983586 15019315103636

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown