BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED TRACHEAL TUBE

    MDR report key: 23352223 · Received October 21, 2025

    Report

    Report Number
    8020889-2025-00421
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    January 13, 2025
    Report Date
    October 21, 2025
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236483 UNSPECIFIED TRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR MALLINCKRODT MEDICAL UNSPECIFIED TRACHEAL TUBE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other