BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA UNCUFFED PEDIATRIC FLEX TEND PLUS TRACHEOSTOMY TUBE

    MDR report key: 3221081 · Received July 3, 2013

    Report

    Report Number
    2183502-2013-00366
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 3, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K944178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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 F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING ROUTINE TRACHEOSTOMY TUBE CHANGE THE DEVICE WAS PLACED IN USE WITH PT. ACCORDING TO REPORTER DURING PLACEMENT THE DEVICE OBTURATOR WAS DIFFICULT TO REMOVE FROM THE TUBE AND DID NOT FIT WITHIN THE TUBE. ACCORDING TO REPORTER AN EMERGENCY TUBE CHANGE WAS PERFORMED WITH ANOTHER TUBE. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305940 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