BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 2310025 · Received October 25, 2011

    Report

    Report Number
    2310025
    Event Type
    Injury
    Date Received
    October 25, 2011
    Date of Event
    February 27, 2011
    Report Date
    March 8, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PTS CUFF ON HIS TRACHEOSTOMY WAS FOUND TO BE DEFLATED. A SYRINGE WAS USED TO PULL BACK CONTENTS AND ONLY AIR WAS RETURNED. PROCEEDED TO TRY AND FILL CUFF WITH STERILE WATER BUT IT DID NOT FILL THE BALLOON. TRACHEOSTOMY TUBE WAS CHANGED DUE TO CONCERN THERE MAY BE A HOLE IN THE CUFF. TRACHEOSTOMY CHANGE WAS UNEVENTFUL. UPON EXAM OF THE OLD TRACHEOSTOMY, IT APPEARED THERE WAS A TEAR IN THE CUFF WITH A PIECE OF SILICONE MISSING. UPON TRYING TO REINFLATE THE CUFF WITH STERILE WATER, IT LEAKED AND THE CUFF WOULD NOT INFLATE. THE PT AND THE BED WERE CHECKED FOR THE MISSING PIECE OF SILICONE BUT IT WAS NOT LOCATED. THE CNC, NNP, AND RT MGR WERE ALL NOTIFIED. THE NNP EXAMINED THE TRACH AND A STAT CHEST X-RAY WAS COMPLETED WITH NO FOREIGN BODY SEEN ON X-RAY. MD AND PEDISURG NOTIFIED. PT THEN UNDERWENT A PEDIATRIC FLEXIBLE FIBER-OPTIC BRONCHOSCOPY IN WHICH THERE WERE NO RETAINED SILICONE FRAGMENTS FROM THE TRACHEOSTOMY TUBE CUFF THAT HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX PEDIATRIC TRACHEOSTOMY TUBE BIVONA SILICONE TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. 1817477

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Required Intervention