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

Model Number	86108-
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Oxygen Saturation (2477)
Date of Event	06/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the endotracheal tube's hub popped off and disconnected from the tube with minimal manipulation of the ventilator circuit while staff were turning the patient.The patient had bradycardia to 40s and oxygen desaturation then code blue was called.Compression started and attempt to ventilate with an ambu bag for 2 minutes without improvement, then continued for 2 more minutes when the disconnection of the hub and tube was noticed.The hub and the tube was reconnected, then a pulse checked confirmed a return of spontaneous circulation.Bagging continued for several more minutes until o2 saturation returned to normal range, then the respiratory therapist exchanged the 3.0 hub with a 3.5 to create a more snug fit to facilitate fewer disconnections.
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: 50107930
• Report Number: 9681384-2026-00780
• Device Sequence Number: 10003081
• Product Code: BTR
• UDI-Device Identifier: 10884522000086
• UDI-Public: (01)10884522000086(17)290124(10)24A0958JZX
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: 86108-
• Device Catalogue Number: 86108-
• Device Lot Number: 24A0958JZX
• 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: 07/08/2026
• Initial Report FDA Received Date: 07/31/2026
• Date Device Manufactured: 01/24/2024
• 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: Other; Life Threatening
• Patient Sex: Unknown