BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA 4.5 TTS HYPERFLEX FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 9090327 · Received September 19, 2019

    Report

    Report Number
    3012307300-2019-04990
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    August 1, 2019
    Report Date
    October 25, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15019517056471
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE PRODUCT EVALUATION (BELOW) WERE NOT INCLUDED IN THE INITIAL SUPPLEMENTAL REPORT. THIS CORRECTION REPORT NOW INCLUDES THE INVESTIGATION RESULTS OF THE RETURNED PRODUCT. EVALUATION RESULTS: TWO CUSTOMIZED 4.5 MM TRACHEOSTOMY TUBES (ID HYPERFLEX FLEXTENDS WITH FIXED CONNECTORS AND TTS CUFFS) WERE RETURNED FOR INVESTIGATION BECAUSE THE DEVICES WERE UNABLE TO INFLATE. BOTH DEVICES WERE INFLATED USING 7 CC'S OF AIR. BOTH DEVICES WERE FULLY INFLATED AND THE INVESTIGATOR NOTES A SMALL AREA STUCK TO THE SHAFT CAUSING THE CUFF TO APPEAR ASYMMETRICAL. THE CUFFS WERE THEN DEFLATED AND GENTLY MASSAGED, AS SPECIFIED IN THE INSTRUCTIONS FOR USE (IFU). THE CUFFS WERE INFLATED AGAIN WITH 7 CC'S OF AIR AND THE CUFFS INFLATED PROPERLY. BOTH DEVICES WERE LEAK TESTED IN A WATER BATH AND NO LEAKS WERE DETECTED.

    Additional Manufacturer Narrative · 1

    RELATED TO MFR NUMBER: 3012307300-2019-04989 (SAME PATIENT WITH TWO SAME DEVICE ISSUES).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA 4.5 TTS HYPERFLEX FLEXTEND TRACHEOSTOMY TUBE CUFF WAS NOT INFLATING PROPERLY WHILE IN USE WITH A PATIENT. THE REPORTER STATED THE PATIENT'S MOTHER WAS IN THE PROCESS OF A TRACHEOSTOMY TUBE CHANGE, BUT WAS UNABLE TO COMPLETE THE CHANGE OUT DUE TO THE EVENT. IT WAS ALSO REPORTED THE PATIENT HAD AN OLD TUBE IN THE HOUSE THAT WAS ABLE TO BE CLEANED AND USED UNTIL A NEW TUBE ARRIVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879546 BIVONA 4.5 TTS HYPERFLEX FLEXTEND TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. XT16DS45NGF009S DS025187 15019517056471

    Patients

    Seq Age Sex Outcome Treatment
    1