BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX BIVONA TTS TRACHEOSTOMY TUBE

    MDR report key: 9673912 · Received February 5, 2020

    Report

    Report Number
    3012307300-2020-00762
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    January 7, 2020
    Report Date
    August 4, 2020
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    JOH
    UDI-DI
    15021312006070
    PMA / PMN Number
    K944178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: FOUR PICTURES OF BIVONA TRACHEOSTOMY TUBES WERE RECEIVED. IN PICTURE 1, A SAMPLE FROM P/N: 670170 IS OBSERVED INSIDE A BAG AND WITH ITS OBTURATOR. IN PICTURE 2, THE ORIGINAL BOX FROM P/N: 670170, L/N: 3801411 IS OBSERVED, IN PICTURE 3, ONE SAMPLE FROM P/N: 670180 IS OBSERVED INSIDE ITS TRAY AND WITH CONTAMINATION IN THE TUBE. IN PICTURE 4, THE ORIGINAL LID FROM P/N: 670180, L/N: 3801409. THREE (3) SAMPLES WERE RECEIVED FROM P/N: 670180, L/N: 3801411 AND P/N: 670180, L/N: 3801409 WITHOUT THEIR ORIGINAL PACKAGING, IN USED CONDITIONS AND WITH THEIR CERTIFICATE OF SAFE HANDLING. VISUAL INSPECTION WAS PERFORMED AT 12" UNDER NORMAL LIGHTING TO RECEIVED UNITS, IN ORDER TO DETECT ANY DAMAGE ON THE CUFF OR AIRLINE. CONTAMINATION WAS OBSERVED ON THE UNITS. THE SAMPLES WERE INFLATED WITH 15CC OF AIR TO SEE IF THERE WAS ANY FUNCTIONAL PROBLEM. WHEN INFLATING THE SAMPLE WITH 15CC OF AIR, THE CUFF IMMEDIATELY DEFLATED. THE SAMPLES WERE TESTED ON LEAK TEST; THE TEST WAS PERFORMED UNDER WATER. WHEN THE UNITS WERE SUBMERGED UNDER WATER, LEAKS WERE FOUND ON THE CUFF. ALL THE LEAKS WERE FOUND IN THE SAME LOCATION OF THE CUFF. THE REPORTED ISSUE WAS ABLE TO BE CONFIRMED. AFTER A REVIEW OF THE DIFFERENT VERIFICATIONS THAT ARE PERFORMED DURING THE MANUFACTURING PROCESS TO DETECT LEAKS, THE MOST PROBABLE CAUSE IS THAT THE DAMAGE OCCURRED AFTER THE PRODUCT LEFT THE MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® BIVONA® TTS¿ TRACHEOSTOMY TUBE WAS REPORTED TO BE LEAKING 2 DAYS FOLLOWING PLACEMENT. THE TUBE WAS CHANGED OUT WITH NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133341 PORTEX BIVONA TTS TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD; INC. 670180 3782499 15021312006070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention