BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE

    MDR report key: 6697687 · Received July 10, 2017

    Report

    Report Number
    3012307300-2017-01443
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Report Date
    March 16, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312005882
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE PATIENT IS A "YOUNG CHILD". THE EXACT AGE IS UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SILICONE ON A PORTEX BIVONA UNCUFFED PEDIATRIC FLEXTEND PLUS SILICONE TRACHEOSTOMY TUBE SPLIT AT THE TOP OF THE SHAFT, AND THE COIL WIRE WAS EXPOSED. THE TRACHEOSTOMY TUBE WAS IN USE WHEN A STAFF MEMBER HEARD AN AUDIBLE LEAK AND THE VENTILATOR ALARMED. THE TRACHEOSTOMY TUBE WAS REMOVED AND A NEW ONE WAS PLACED IMMEDIATELY. IT WAS AFTER REMOVAL THAT THE SPLIT IN THE SILICONE WAS OBSERVED. IT WAS NOTED THAT THE TRACHEOSTOMY TUBE HAD "ONLY BEEN USED TWICE". NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480122 PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3051837 15021312005882

    Patients

    Seq Age Sex Outcome Treatment
    1