BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    MDR report key: 5876094 · Received August 15, 2016

    Report

    Report Number
    2183502-2016-01710
    Event Type
    Injury
    Date Received
    August 15, 2016
    Date of Event
    June 27, 2016
    Report Date
    July 19, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K): K914088 & K083641. THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ONE USED 3.5MM TTS V NECK FLANGE CUSTOM TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH ANOTHER TRACHEOSTOMY TUBE. VISUAL INSPECTION REVEALED THAT THE DEVICE WAS MISSING ONE OF THE WINGS ON THE NECK FLANGE. INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE MISSING THE MISSING WING. (B)(4).

    Description of Event or Problem · 1

    SUPPLIER REPORTED ON BEHALF OF CUSTOMER THAT THE BIVONA CUSTOM TRACHEOSTOMY TUBE HAD THE FLANGE BREAK DURING THERAPY. PATIENT DESATURATED AND REQUIRED EMERGENCY TRACHEOSTOMY TUBE CHANGE AND BAGGING. NO FURTHER ADVERSE EVENTS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528855 BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R