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); Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	03/28/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that at 19:21 on (b)(6) 2026, the patient was admitted to the department due to acute heart failure.At 19:35, the patient developed significant dyspnea.As prescribed, propofol was administered intravenously for sedation, and oral endotracheal intubation was performed with insertion depth of 24 cm.The patient was then connected to a ventilator for assisted ventilation.From 23:00 on (b)(6) to 08:30 on (b)(6), the bedside nurse checked the cuff pressure every two hours and found it to be deflated each time.The ventilator frequently alarmed, indicating insufficient ventilation and low tidal volume for a total of 8h.During the night, multiple attempts to inflate the cuff using a cuff pressure monitor failed to detect cuff pressure or leakage, and cuff damage was suspected.At 08:30, the anesthesiology team assisted at the bedside to replace the tube.After replacement, the patient¿s oxygen saturation returned to normal and ventilator parameters stabilized.Inspection revealed that the cuff of the removed tube was leaking and damaged.

• 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 55112-4391 ; 8006464633
• MDR Report Key: 25023402
• Report Number: 9681384-2026-00509
• Device Sequence Number: 21397629
• Product Code: BTR
• UDI-Device Identifier: 40884521032539
• UDI-Public: (01)40884521032539(17)300331(10)25C1569JZX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 18875
• Device Catalogue Number: 18875
• Device Lot Number: 25C1569JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 03/31/2025
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 72 KG