BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA NEO V NECK FLANGE TRACHEOSTOMY TUBE

    MDR report key: 19314749 · Received May 14, 2024

    Report

    Report Number
    9617604-2024-00437
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 10, 2024
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    JOH
    UDI-DI
    15021312006223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D9. DATE RETURNED TO MFG: 11-JUN-2024. H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: THE SAMPLE RETURNED CONSISTS OF ONE (1) FOR P/N: 67N035 AND L/N: 3884266, RETURNED SAMPLE WAS RECEIVED USED, IN A PLASTIC BAG. DURING THE VISUAL INSPECTION IT WAS IDENTIFIED THAT A PORTION OF THE CUFF WAS STUCK TO THE TUBE. HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE, THE CUFF WAS MASSAGED WHILE THE PILOT BALLOON WAS SQUEEZED, AND THE CUFF INFLATED. SYMMETRY MEASUREMENT WAS PERFORMED TO CONFIRM IF THE VALUE WAS LESS THAN 33%. THE SYMMETRY VALUE WAS 47% (9/19*100). THE FAILURE MODE OF A0492 - WILL NOT INFLATE WAS NOT CONFIRMED. CAPA-000862 WAS OPENED ON JANUARY 5TH, 2022, TO ADDRESS ROOT CAUSE INVESTIGATION CUFFED PRODUCTS DO NOT INFLATE SYMMETRICALLY. 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

    REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. 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

    IT WAS REPORTED THAT THE CUFF ONLY INFLATED ON ONE SIDE. CUSTOMER TRIED TO KEEP CUFF INFLATED FOR AN HOUR WITH NO CHANGE. THE OTHER TUBE DID NOT INFLATE AT ALL. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102760 BIVONA NEO V NECK FLANGE TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 3884266 15021312006223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown