BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM BIVONA TRACHEOSTOMY TUBE

    MDR report key: 5806627 · Received July 19, 2016

    Report

    Report Number
    2183502-2016-01535
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    May 1, 2016
    Report Date
    May 1, 2024
    Manufacturer
    SMITHS MEDICAL ASD INC.,
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE USED 6.0MM TTS¿ CUSTOM STANDARD CURVE TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE FOUND THAT THE FLANGE EYELET WAS SPLIT. UPON REVIEW OF THE COMPLAINANT'S DESCRIPTION, IT WAS NOTED THAT THE PATIENT USED VELCRO NECK TIES TO SECURE THE TRACHEOSTOMY TUBE DURING USE. THE USE OF VELCRO NECK TIES, WHICH HAVE SHARP EDGES, CAN RESULT IN THE TEARING OF THE SILICONE OF THE DEVICE EYELETS. THE DEVICE INSTRUCTIONS FOR USE RECOMMENDS TO USE THE PROVIDED TWILL TIES TO HOLD THE TRACHEOSTOMY TUBE IN PLACE. MFR# CLARIFICATION: NEW REGISTRATION NUMBER (B)(4) (MINNEAPOLIS, MN) HAS BEEN RECEIVED, HOWEVER, THIS INITIAL MDR WAS FILED UNDER THE PRIOR REGISTRATION NUMBER (B)(4)).

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE USED 6.0MM TTS CUSTOM STANDARD CURVE TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE FOUND THAT THE FLANGE EYELET WAS SPLIT. UPON REVIEW OF THE COMPLAINANT'S DESCRIPTION, IT WAS NOTED THAT THE PATIENT USED VELCRO NECK TIES TO SECURE THE TRACHEOSTOMY TUBE DURING USE. THE USE OF VELCRO NECK TIES, WHICH HAVE SHARP EDGES, CAN RESULT IN THE TEARING OF THE SILICONE OF THE DEVICE EYELETS. THE DEVICE INSTRUCTIONS FOR USE RECOMMENDS TO USE THE PROVIDED TWILL TIES TO HOLD THE TRACHEOSTOMY TUBE IN PLACE. (B)(4).

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. CUSTOMIZED TRACH (B)(4). PMA/510(K): K913859 & K083641.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLANGE OF THE CUSTOM BIVONA TRACHEOSTOMY TUBE HAD BROKEN AND THE TRACHEOSTOMY ALMOST BECOME DISLODGED ON A VENT DEPENDENT CLIENT THAT CANNOT TOLERATE SPRINTING OFF A VENTILATOR. HOME HEALTH NURSE AND MOTHER OF PATIENT OBSERVED FAILURE AND AN EMERGENT TRACH CHANGE WAS PERFORMED BY THE NURSE. THIS TRACH HAS BEEN PROCESSED; HAD BEEN IN USE SINCE (B)(6) 2016 UNTIL IT BROKE ON OCCURRENCE DATE. PARENT FOLLOWS CLEANING GUIDELINES. USED WITH A PEPPER 301 PEDIATRIC VELCRO NECK TIES TO HOLD TRACH. UNKNOWN PATIENT'S CONDITION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457458 CUSTOM BIVONA TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC.,

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Life Threatening| R