BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 23042910 · Received September 12, 2025

    Report

    Report Number
    9681384-2025-00993
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 27, 2025
    Report Date
    November 24, 2025
    Manufacturer
    COVIDIEN AG JUAREZ (MMJ)
    Product Code
    BTR
    UDI-DI
    10884522007597
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3 AND H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE CUFF PRESENTED A SMALL CUT. FUNCTIONALLY, AN INFLATION/DEFLATION TEST WAS PERFORMED. AIR WAS APPLIED TO THE CUFF USI NG A SYRINGE AND IT WAS OBSERVED THAT THE CUFF DEFLATED IMMEDIATELY. IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE EXPERIENCED CUFF AIR LEAKAGE BEFORE USE, AT THE HOSPITAL. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS DETERMINED TO BE MANUFACTURING REL ATED. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. 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 ENDOTRACHEAL TUBE EXPERIENCED CUFF AIR LEAKAGE BEFORE USE, AT THE HOSPITAL. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170882 SHILEY TUBE, TRACHEAL (W/WO CONNECTOR) BTR COVIDIEN AG JUAREZ (MMJ) 18770 24L0808JZX 10884522007597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown