BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS TRACHEOSTOMY TUBES

    MDR report key: 5846231 · Received August 4, 2016

    Report

    Report Number
    2183502-2016-01658
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    May 11, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. POSSIBLE LOT NUMBERS: 2844620 OR 2927315. PMA/ 510(K) #: K913859 & K083641.

    Additional Manufacturer Narrative · 1

    THE REPORTED 8.5MM TTS¿ TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION WITH 3 OTHER TRACHEOSTOMY TUBES. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT, FOUND NO ISSUES OR NON-CONFORMITIES DURING INVESTIGATION. VISUAL INSPECTION FOUND THAT A PORTION OF THE AIRWAY BALLOON, THAT RETAINS THE PLASTIC VALVE, WAS COMPLETELY CUT OFF AND MISSING. DURING FUNCTIONAL TESTING, A SYRINGE WAS USED TO INFLATE THE DEVICE CUFF; HOWEVER, THE CUFF WAS UNABLE TO MAINTAIN INFLATION DUE TO THE CUT ON THE AIRWAY BALLOON. THE COMPLAINANT'S DESCRIPTION OF "BALLOON COLLAPSED IN ON ITSELF" WAS NOT OBSERVED DURING INVESTIGATION, POSSIBLY DUE TO THE COMPLAINANT ALTERING THE DEVICE. INVESTIGATION WAS NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, NO EVIDENCE WAS FOUND TO SUGGEST A MANUFACTURING DEFECT. (B)(4).

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). THE CARE ASSESSOR REPORTED ON BEHALF OF THE PATIENT THAT THE BIVONA TTS TRACHEOSTOMY TUBE BALLOON COLLAPSED IN ON ITSELF. THE WORKER TRIED TO SALVAGE THE TUBE BY CUTTING THE BALLOON AND REINSERTING THE SYRINGE JUNCTION TUBE BACK INTO THE BALLOON. THE TUBE ENDED UP GETTING CHANGED. THERE WAS NO REPORTED INFORMATION ON THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498366 BIVONA TTS TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR