BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX

    MDR report key: 10806574 · Received November 8, 2020

    Report

    Report Number
    3012307300-2020-11241
    Event Type
    Injury
    Date Received
    November 8, 2020
    Date of Event
    September 21, 2020
    Report Date
    January 9, 2021
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H 10 ADDITIONAL INFORMATION.: DATE OF EVENT REVEALED: (B)(6) 2019. MEDICAL DETAILS: NO INJURY, BUT THE PATIENT EXPERIENCED DISCOMFORT FROM REMOVING AND INSERTING THE TUBE. DOCTOR DID NO FELT INSECURE WITH PRODUCT. REPORT CHANGED TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE USED DECONTAMINATED 007/910/685 BLU TRACHEOSTOMY TUBE 8.5MM S/ASSY 1/EA WAS RECEIVED FOR INVESTIGATION WITHOUT ITS ORIGINAL PACKAGING (SEE PHOTO OF SAMPLE). 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 OBSERVED THAT IT IS NOT EVEN POSSIBLE TO INFLATE CUFF BECAUSE IT LEAKS SO BADLY FROM APP. 1MM LONG TEAR IN CUFF. EACH CUFF SHALL BE ALSO TESTED BY CUSTOMER PRIOR USE AS PER INSTRUCTION FOR USE LLS10001031-001 REV. 100, PAGE 3, INSTRUCTION FOR USE SECTION, POINT 1: "THE INTEGRITY OF THE CUFF AND INFLATION SYSTEM SHOULD BE CHECKED PRIOR TO INSERTION". DUE TO FACT THAT CUFF LEAK WAS OBSERVED AFTER TRACHEOSTOMY PROCEDURE IT IS THE MOST PROBABLE THAT CUFF TEAR OCCURRED DURING OR AFTER TRACHEOSTOMY PROCEDURE DUE TO CONTACT WITH SHARP EDGE WHICH IS IN CONFLICT WITH INSTRUCTION FOR USE LLS10001031-001 REV. 100, PAGE 5, PRECAUTIONS SECTION, POINT 6 "GUARD AGAINST CUFF DAMAGE BY AVOIDING CONTACT WITH SHARP EDGES".

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION IN H 10.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARY IN H 10.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS PLACED IN USE WITH PATIENT AND THE CUFF WAS FOUND TO LEAK. NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271317 PORTEX TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/810/085CZ 3876887

    Patients

    Seq Age Sex Outcome Treatment
    1