BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY

    MDR report key: 23881817 · Received December 23, 2025

    Report

    Report Number
    9681384-2025-01391
    Event Type
    Death
    Date Received
    December 23, 2025
    Date of Event
    November 22, 2025
    Report Date
    December 23, 2025
    Manufacturer
    COVIDIEN AG JUAREZ (MMJ)
    Product Code
    BTR
    UDI-DI
    10884521815278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 87475, 87475 SHILEY ORAL NASAL INTERMEDIATE 7.5, LOT # 25D1122JZX. 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

    IT WAS REPORTED THAT DURING INTUBATION WITH TWO ENDOTRACHEAL TUBES INVOLVED, THE PATIENT DIED. ALLEGATIONS INCLUDED THAT THE ENDOTRACHEAL TUBES HAD SLOW PUNCTURES AND THE CUFFS WERE DEFLATING WHILE THE PATIENT WAS INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2533161 SHILEY TUBE, TRACHEAL (W/WO CONNECTOR) BTR COVIDIEN AG JUAREZ (MMJ) 87475 25D1122JZX 10884521815278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SEE NOTES ON H11