BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 6573171 · Received May 17, 2017

    Report

    Report Number
    3012307300-2017-01053
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Report Date
    July 28, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    UDI-DI
    15021312000375
    PMA / PMN Number
    K912469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): ADDITIONAL 510(K): K083641. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    ONE DEVICE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING OF THE DEVICE INVOLVED A TAPER GAGE CHECK AND FOUND THE COMPONENTS WITHIN DIMENSIONAL SPECIFICATIONS AND THAT THE INSERTION OF THE CONNECTOR INTO THE HME FILTER HAD NO ISSUES. IT WAS INDICATED THAT THE HME ADAPTER WOULD NOT SEPARATE FROM THE CONNECTOR IF TOO MUCH FORCE WAS APPLIED. A REVIEW OF THE DEVICE MASTER RECORD WAS PERFORMED AND FOUND TO BE COMPLETE. THE INVESTIGATION DID NOT REVEAL ANY INTRINSIC MANUFACTURING DEFECTS. BASED ON THE EVIDENCE, THE ROOT CAUSE WAS ATTRIBUTED TO A USER ERROR, DUE TO THE USER INTERFACING WITH THE PRODUCT IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PARENTS COULD NOT REMOVE THE HEAT MOISTURE EXCHANGER (HME) FROM THE HUB OF A PORTEX® BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE. IT WAS NOTED THAT THE EVENT RESULTED IN "DECANNULATION". NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01052.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354503 PORTEX® BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC. 3166696 15021312000375

    Patients

    Seq Age Sex Outcome Treatment
    1