BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS TRACHEOSTOMY TUBES

    MDR report key: 5846140 · Received August 4, 2016

    Report

    Report Number
    2183502-2016-01659
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    May 27, 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, RELEVANT TO THE REPORTED LOT, FOUND NO NON-CONFORMITIES OR ISSUES DURING MANUFACTURING. DURING VISUAL INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE AIRWAY BALLOON WAS COMPLETELY DETACHED FROM THE AIRWAY LINE. FURTHER EXAMINATION, FOUND THAT THE AIRWAY LINE WAS STILL PRESENT INSIDE THE BALLOON AND THAT THE BREAK OCCURRED OUTSIDE OF THE BALLOON. THE PRESENCE OF THE AIRWAY LINE INSIDE THE BALLOON INDICATED THAT THE BOND BETWEEN THE AIRWAY LINE AND BALLOON WAS SUFFICIENT TO RETAIN THE AIRWAY LINE. INVESTIGATION, WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUT IN THE AIRWAY LINE; HOWEVER, NO EVIDENCE WAS FOUND TO SUGGEST AN INTRINSIC PRODUCT 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 MUST HAVE GOT CAUGHT ON SOMETHING AS THE BALLOON CAME APRT FROM THE INFLATION LINE. THE TUBE ENDED UP GETTING CHANGED. THERE WAS NO REPORTED INFORMATION ON THE PATIENTS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499035 BIVONA TTS TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR