BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES

    MDR report key: 5800237 · Received July 16, 2016

    Report

    Report Number
    2183502-2016-01521
    Event Type
    Malfunction
    Date Received
    July 16, 2016
    Date of Event
    June 20, 2016
    Report Date
    June 20, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.,
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. 510K : K914088, K083641.

    Additional Manufacturer Narrative · 1

    THE REPORTED 4.0 TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION SHOWED A CRACK IN THE SIDE OF THE PLASTIC CONNECTOR. FUNCTIONAL TESTING WAS PERFORMED AND THE CUFF WAS INFLATED WITH 7CC OF AIR USING LEAK TEST PROCEDURE; NO LEAKS WERE DETECTED. IT WAS ALSO OBSERVED THAT THE OD OF THE PLASTIC CONNECTOR WAS DEFORMED AND BULGING NEAR THE MIDDLE OF THE CONNECTOR. THE DEFORMATION MAY HAVE BEEN CAUSED BY EXPOSING THE DEVICE TO A HIGH TEMPERATURE. THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER REPORTED THAT THERE WAS A CRACK IN THE CONNECTOR OF THE BIVONA TTS CUFFED NEONATAL AND PEDIATRIC SILICONE TRACH AROUND 6 MILLIMETERS LONG. THE CHILD STILL USED THIS SPECIFIC TRACHEOSTOMY DUE TO THAT THE CRACK HASN'T GOT THROUGH THE MATERIAL. NO PATIENT INJURY KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454202 PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC., 2983238

    Patients

    Seq Age Sex Outcome Treatment
    1