BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    MDR report key: 5876107 · Received August 15, 2016

    Report

    Report Number
    2183502-2016-01709
    Event Type
    Injury
    Date Received
    August 15, 2016
    Date of Event
    May 11, 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 REPORTED BIOVANA TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT ONE ON THE WINGS ON THE NECK FLANGE WAS MISSING. USING 10CC OF AIR A LEAK TEST WAS PERFORMED AND A LEAK WAS NOT INITIALLY APPARENT. THE DEVICE APPEARED TO MAINTAIN ITS VOLUME. ONLY AFTER MANIPULATIONS AND APPLYING PRESSURE AND 10CC OF WATER TO THE PILOT BALLOON WAS AN INSIDE LEAK WHERE THE TEFLON TUBING JOINS THE AIRWAY LINE TO THE INSIDE LUMEN IDENTIFIED. ROOT CAUSE COULD HAVE OCCURRED WHEN NOTCHING THE OUTSIDE LUMEN WALL IN PREPARATION FOR INSERTING THE TEFLON TUBING DURING MANUFACTURING.

    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.

    Description of Event or Problem · 1

    SUPPLIER REPORTED ON BEHALF OF CUSTOMER THAT THE BIVONA CUSTOM TRACHEOSTOMY TUBE THAT THE CUFF WAS LEAKING DURING THERAPY UPON INITIAL USE. PATIENT DESATURATED AND REQUIRED EMERGENCY TRACHEOSTOMY TUBE CHANGE AND BAGGING. ADDITIONAL INFORMATION RECEIVED REPORTED THE TRACHEOSTOMY CUFF PATENCY WAS TESTED PRIOR TO USE. TRACHEOSTOMY WAS USED WITH VELCRO TIES AND CUFF WAS FILLED WITH 2ML SALINE DURING USE. THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527994 BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Life Threatening| R