BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA AIRE-CUF NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 3080687 · Received April 8, 2013

    Report

    Report Number
    2183502-2013-00133
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K912469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND 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

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE REQUIRED REMOVAL AND REPLACEMENT. IT IS ALLEGED THAT AFTER AN UNK AMOUNT OF TIME IN SITU THE TUBE SHAFT WAS TORN EXPOSING THE INTERNAL WIRE. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142632 BIVONA AIRE-CUF NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA 2113274

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK