MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) Shiley; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	18875
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Hypoventilation (1916); Unintended Extubation (4564)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ventilator alarmed, the tidal volume had decreased significantly, and the tidal volume fluctuated widely.Gas was observed being exhaled from the patient¿s mouth, inflating the cuff was ineffective, and the cuff pressure was found to be significantly low.External factors such as circuit disconnection, water accumulation, and air trapping were ruled out, and cuff leakage was considered.The ventilator oxygen concentration was adjusted to 100%, secretions and saliva were fully suctioned, the original endotracheal tube was removed and replaced, and the procedure went smoothly.After reconnection to the ventilator, the alarm disappeared, the original ventilator oxygen concentration was restored, and after 5 minutes of observation, oxygen saturation was 100%.
Additional Manufacturer Narrative
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.

• Brand Name: Shiley
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50244300
• Report Number: 9681384-2026-00817
• Device Sequence Number: 9752682
• Product Code: BTR
• UDI-Device Identifier: 40884521032539
• UDI-Public: (01)40884521032539(17)301002(10)25J0041JZX
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 18875
• Device Catalogue Number: 18875
• Device Lot Number: 25J0041JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 10/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Unknown
• Patient Weight: 132 LB