BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 18812575 · Received February 29, 2024

    Report

    Report Number
    9617604-2024-00195
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    February 3, 2024
    Report Date
    April 3, 2024
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    JOH
    PMA / PMN Number
    K083641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D.2. COMMON DEVICE NAME: TUBE, TRACHEOSTOMY (W/WO CONNECTOR). D.2. MEDICAL DEVICE TYPE: BTO. D5. OTHER OPERATOR OF DEVICE: OPERATOR OF DEVICE IS UNKNOWN. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: G.5. PMA / 510(K)#: K912469. 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.

    Additional Manufacturer Narrative · 0

    H3. AND H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: THE SAMPLE RETURNED CONSISTS OF ONE (1) FOR P/N: (B)(6)AND LOT: 4335085, RETURNED SAMPLE WAS RECEIVED IN USED CONDITION, IN A PLASTIC BAG. DURING THE VISUAL INSPECTION IT WAS IDENTIFIED THAT THE TUBE HAD A BROKEN FLANGE/NECK STRAP. THE CUSTOMER IDENTIFIED THE ISSUE AFTER ONE WEEK OF USE. THE FAILURE MODE OF ¿SEPARATION¿ WAS CONFIRMED. A CAPA WAS OPENED TO ADDRESS A FULL ROOT CAUSE INVESTIGATION FOR DAMAGED FLANGE/NECK STRAP ISSUES, WHICH IS CURRENTLY IN ITS IMPLEMENTATION PHASE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE LEFT FLANGE OF THE TRACHEOSTOMY TUBE BROKE AND DROPPED AT THE BASE, DURING USE. THIS CAUSED THE PATIENT TO LOSE SOME OXYGEN SATURATION BEFORE ANOTHER TUBE WAS PLACED. THIS WAS THE SECOND REPORTED INCIDENT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213113 BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4335085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention