BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA NEONATAL TIGHT TO SHAFT TRACH TUBE

    MDR report key: 19274503 · Received May 8, 2024

    Report

    Report Number
    3012307300-2024-03544
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 4, 2024
    Report Date
    July 16, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006223
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE AFFECTED DEVICE WAS RETURNED FOR EVALUATION. DURING VISUAL INSPECTION IT WAS IDENTIFIED THAT ONE PORTION OF THE CUFF WAS ADHERED TO THE TUBE. THE CUFF WAS MASSAGED WHILE THE PILOT BALLOON WAS SQUEEZED AND THE CUFF INFLATED SYMMETRICALLY. THE TEST IS DONE ACCORDING TO THE INSTRUCTIONS FOR USE. THE FAILURE OF THE BROKEN CUFF WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Additional Manufacturer Narrative · 0

    H3 - OTHER: DEVICE HAS NOT BEEN RETURNED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED: " ON THE AFTERNOON OF 04-APR-2024, DURING A PATIENT'S TRACHEOSTOMY TUBE CHANGE BY THE ORL DOCTOR AND THE MEDICAL AND PARAMEDICAL TEAMS IN THE PEDIATRIC INTENSIVE CARE UNIT, DAMAGED AND NON-COMPLIANT CANNULAS (GLUED CUFF AND GLUED AND DAMAGED PLASTIC) WERE FOUND. AFTER OPENING 5 DIFFERENT BOXES, THEY FINALLY FOUND A USABLE CANNULA." THERE WAS PATIENT INVOLVEMENT, BUT THERE WERE NO CONSEQUENCES OF THE EVENT. THERE WAS RISK OF DETERIORATION OF THE PATIENT'S CONDITION (RISK OF INFECTIOUS HYGIENE OR RESPIRATORY INFECTION) IF THE DAMAGED CANNULA MAY HAVE BEEN USED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE NUMBER OF DEVICES INVOLVED FROM LOT 3904655 IS 2, BUT ONLY ONE IS AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519412 BIVONA NEONATAL TIGHT TO SHAFT TRACH TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3904655 15021312006223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown