BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA UNCUFFED PEDIATRIC FLEXTEND PLUS TRACHEOSTOMY TUBE

    MDR report key: 3203701 · Received June 25, 2013

    Report

    Report Number
    2183502-2013-00345
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K944178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORDS AND VISUAL INSPECTION OF THE RETURNED SAMPLE FOUND NO ISSUES. MEASUREMENTS OF THE DIMENSIONS OF THE RETURNED SAMPLE ALSO CONFIRMED THE PRODUCT HAD BEEN MANUFACTURED TO SPECIFICATION. FUNCTIONAL TESTING FOUND THE OBTURATOR TO BE INSERTED AND REMOVED FROM THE TUBE WITHOUT DIFFICULTY.

    Description of Event or Problem · 1

    ACCORDING TO REPORTER, THE USER'S CAREGIVER (PT'S PARENT) TESTED THE OBTURATOR FITTING WITHIN THE TRACHEOSTOMY TUBE. DURING THIS TESTING, THE OBTURATOR COULD BE REMOVED FROM TUBE SUCCESSFULLY. ACCORDING TO REPORTER, THE PT'S PARENT THEN INSERTED THE DEVICE INTO PT AND HAD DIFFICULTY REMOVING THE OBTURATOR FROM THE TUBE. ACCORDING TO REPORTER, THE PT'S PARENT AND NURSING STAFF THEN PERFORMED AN EMERGENCY EXCHANGE OF THE TUBE. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288024 BIVONA UNCUFFED PEDIATRIC FLEXTEND PLUS TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA 2371457

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other