BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA ADULT TTS TRACHEOSTOMY TUBE

    MDR report key: 9894838 · Received March 28, 2020

    Report

    Report Number
    3012307300-2020-02396
    Event Type
    Malfunction
    Date Received
    March 28, 2020
    Date of Event
    February 11, 2020
    Report Date
    July 12, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT TTS . P/N 670180 L/N 3800558 WAS TESTED AND CONFIRMED WITH TWO SAMPLES SUBMERGED IN WATER. LEAKS WERE DETECTED IN BOTH AND CUSTOMERS COMPLAINT WAS CONFIRMED. WHEN INFLATING CUFFS WITH 20 CC OF AIR THERE WAS NO FUNCTIONAL ISSUES DETECTED, AS THE CUFFS INFLATED AND DEFLATED. A REVIEW OF THE MANUFACTURING PROCESS FOR P/N 670170-SA AND L/N 3975191, WAS CONDUCTED BY QUALITY ENGINEER ON 13/MAY/2020 IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT AS DESCRIBED IN "DESCRIPTION OF NON-CONFORMANCE" SECTION. ALL PROCEDURES ARE BEING CARRIED APPROPRIATE. IF IS BELIEVED THE DAMAGE WAS CAUSED AFTER LEAVING THE FACILITY. UPDATED FIELDS. B 1 B 3 B 4 B 5 G 7 H 1 H 2 H 3 H 6 H 10

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY SILICONE -BIVONA TUBE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT SMITHS BIVONA® ADULT TTS¿ TRACHEOSTOMY TRACHEOSTOMY/SILICONE - WAS INSERTED ON (B)(6) 2020 BUT ON (B)(6) IT WAS NOTICED THE TRACHESOTOMY HAD A LEAK. WHEN PRECHECK WAS DONE FOR CHANGE OUT OF DEVICE, THAT WAS ALSO NOTED TO HAVE A LEAK. THIS RESULTED IN TWO COMPLAINTS. TRACH WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356229 BIVONA ADULT TTS TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD,INC. CUSTOM 4.0 FLEXTEND TTS NS +1/EA 3800558 NOT VALID 15021312006070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention