BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 23009702 · Received September 9, 2025

    Report

    Report Number
    9681384-2025-00960
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 9, 2025
    Manufacturer
    COVIDIEN AG JUAREZ (MMJ)
    Product Code
    BTR
    UDI-DI
    40884521032539
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT AFTER THE PATIENT'S AORTIC DISSECTION SURGERY, ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) COULD NOT BE RULED OUT, WITH AN OXYGENATION INDEX OF APPROXIMATELY 150. THE SPONTANEOUS BREATHING TRIAL (SBT) WAS UNSUCCESSFUL, MAKING EXTUBATION IMPOSSIBLE WITH LESS THAN 30 MINUTES. A CUFF LEAKAGE OF THE ENDOTRACHEAL TUBE WAS DISCOVERED. THE ENDOTRACHEAL TUBE WAS REPLACED, WHICH RESULTED IN A DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2835436 SHILEY TUBE, TRACHEAL (W/WO CONNECTOR) BTR COVIDIEN AG JUAREZ (MMJ) 18875 25A1409JZX 40884521032539

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Life Threatening| R