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

Model Number	18865
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Hypoventilation (1916); Respiratory Failure (2484); Respiratory Arrest (4461); Unintended Extubation (4564)
Date of Event	11/20/2025
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 the pilot balloon of the endotracheal tube had several leaks.There was problems maintaining cuff pressure, requiring repeated re-inflation, sometimes every 10 minutes, to ensure a proper seal.The patient had respiratory arrest, with suspected mucus plugging and bronchoaspiration.In addition, balloon malfunctions make it difficult to maintain adequate ventilatory pressure and pose risks due to repeated manipulation of the tube.
Additional Manufacturer Narrative
Additional information: b5, b7, g3, h6, fdp (respiratory arrest), fdp (aspiration), fdp (resuscitation), imf (resuscitation), fdp (delay to treatment/therapy), imf (delay to treatment/therapy), imf (additional device required).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 the pilot balloon of the endotracheal tube had several leaks.There was problems maintaining cuff pressure, requiring repeated re-inflation, sometimes every 10 minutes, to ensure a proper seal.The patient had respiratory arrest, with suspected mucus plugging and bronchoaspiration.In addition, balloon malfunctions make it difficult to maintain adequate ventilatory pressure and pose risks due to repeated manipulation of the tube.Resuscitation was done.

• 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: 24399630
• Report Number: 9681384-2026-00228
• Device Sequence Number: 9730881
• Product Code: BTR
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2026

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: 18865
• Device Catalogue Number: 18865
• Device Lot Number: 22C1121JZX
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 07/17/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/12/2026; 07/21/2026
• Date Device Manufactured: 03/14/2022
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown