BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX BLUSELECT TRACHEOSTOMY TUBE

    MDR report key: 14193983 · Received April 25, 2022

    Report

    Report Number
    3012307300-2022-06938
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 25, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019315104862
    PMA / PMN Number
    K030570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    ONE USED DECONTAMINATED SAMPLE 007/910/880 8MM BLU SUCTIONAID SUB-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 CONFIRMED THAT AFTER 12 HOURS THE CUFF WAS STILL FULLY INFLATED. BASED ON RESULTS OF TESTING THE REPORTED FAILURE WAS NOT OBSERVED. NO TREND OF SIMILAR CUSTOMER COMPLAINTS WAS IDENTIFIED. A DHR WAS NOT COMPLETED SINCE NO FAULT WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEAKING TRACHEOSTOMY TUBE CUFF. THE PATIENT REQUIRED AN EARLIER TRACHEOSTOMY CHANGE. UPON DECANNULATION, THE HCP NOTED THAT A 'BUILD OF BUBBLE' WAS NOTED WITHIN THE CUFF. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796280 PORTEX BLUSELECT TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/870/080CZ 4155447 15019315104862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown