BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA UNCUFFED PEDIATRIC FLEX TEND PLUS TRACHEOSTOMY TUBE

    MDR report key: 1933795 · Received December 13, 2010

    Report

    Report Number
    2183502-2010-00571
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 25, 2010
    Report Date
    December 6, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K944178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATES THAT A VENTILATOR HOSE COULD NOT BE REMOVED FROM THE 15MM CONNECTOR OF THE IN SITU TRACHEOSTOMY TUBE. AN EMERGENT REPLACEMENT WAS REQUIRED. NO FURTHER INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA UNCUFFED PEDIATRIC FLEX TEND PLUS TRACHEOSTOMY TUBE JOH-TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other