BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY

    MDR report key: 23816943 · Received December 16, 2025

    Report

    Report Number
    9681384-2025-01360
    Event Type
    Death
    Date Received
    December 16, 2025
    Date of Event
    November 27, 2025
    Report Date
    March 4, 2026
    Manufacturer
    COVIDIEN AG JUAREZ (MMJ)
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE SAMPLE WAS RECEIVED OUTSIDE ITS POUCH AND IT WAS OBSERVED THAT THE CUFF PRESENTED A SMALL CUT. FUNCTIONALLY, AN INFLATION/DEFLATION TEST WAS PERFORMED. AIR WAS APPLIED TO THE CUFF USING A SYRINGE, AND IT WAS OBSERVED THAT THE CUFF DEFLATED IMMEDIATELY. IT WAS REPORTED THAT THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS BROKEN AND HAD AN AIR LEAKAGE. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: EACH TUBE¿S CUFF, PILOT BALLOON AND VALVE SHOULD BE TESTED BY INFLATION PRIOR TO USE. IF DYSFUNCTION IS DETECTED IN ANY PART OF THE INFLATION SYSTEM, THE TUBE SHOULD NOT BE USED AND SHOULD BE RETURNED. THE USE OF LIDOCAINE TOPICAL AEROSOL HAS BEEN ASSOCIATED WITH THE FORMATION OF PINHOLES IN PVC CUFFS. LIDOCAINE HYDROCHLORIDE SOLUTION HAS BEEN REPORTED NOT TO HAVE THIS EFFECT. DO NOT OVERINFLATE THE CUFF. ORDINARILY, THE CUFF PRESSURE SHOULD NOT EXCEED 25 CMH2O. OVERINFLATION CAN RESULT IN TRACHEAL DAMAGE, RUPTURE OF THE CUFF WITH SUBSEQUENT DEFLATION, OR IN CUFF DISTORTION WHICH MAY LEAD TO AIRWAY BLOCKAGE. DEFLATE THE CUFF PRIOR TO REPOSITIONING THE TUBE. MOVEMENT OF THE TUBE WITH THE CUFF INFLATED COULD RESULT IN PATIENT INJURY, REQUIRING POSSIBLE MEDICAL INTERVENTION OR DAMAGE TO THE CUFF. VARIOUS BONY ANATOMICAL STRUCTURES (E.G., TEETH, TURBINATES) WITHIN THE AIRWAY OR ANY INTUBATION TOOLS WITH SHARP SURFACES MIGHT JEOPARDIZE CUFF INTEGRITY. DAMAGE TO THE THIN-WALLED CUFF DURING INSERTION WILL SUBJECT THE PATIENT TO THE RISK OF EXTUBATION AND RE-INTUBATION. IF THE CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED. 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.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 18775, 18775 7.5MM TAPERGUARD TRACHEAL TUBEX10, (LOT# UNKNOWN). 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 THE CUFFS OF THE TWO ENDOTRACHEAL TUBES WERE BROKEN AND HAD AN AIR LEAKAGE. THERE WAS NO AIR LEAKAGE AFTER THE THIRD ETT INTUBATION. THE PATIENT WAS GONE WITHOUT ANY SURGERY PROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3498 SHILEY TUBE, TRACHEAL (W/WO CONNECTOR) BTR COVIDIEN AG JUAREZ (MMJ) 18775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SEE H11