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

Model Number	86450
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Insufficient Information (4580)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the endotracheal tube's top adapter was easily removed from the tube itself and the issue occurred when removing the stylet.There was no reported patient outcome.
Additional Manufacturer Narrative
D10 concomitant product: 18885 8.5mm taperguard evac trachealx10 lot: 25g0377jzx 18885 8.5mm taperguard evac trachealx10 lot: 25g0376jzx 18880 8.0mm taperguard evac trachealx10 lot: 25f0326jzx 18875 7.5mm taperguard evac trachealx10 lot: 25g0050jzx 18875 7.5mm taperguard evac trachealx10 lot: 25i0307jzx 18870 7.0mm taperguard evac trachealx10 lot: 25h0038jzx 18865 6.5mm taperguard evac trachealx10 lot: 25g0392jzx 18865 6.5mm taperguard evac trachealx10 lot: 25g0389jzx 18860 6.0mm taperguard evac trachaelx10 lot: 25g0403jzx 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 when the first responders arrived on the scene, the patient was already in cardiac arrest, resuscitation was initiated, and the patient was intubated as a part of the resuscitative efforts.The endotracheal tube's 15mm disconnected right after the intubation procedure was performed as the stylet was being removed from the tube.The first responder resolved the issue by reconnecting the same 15mm connector back onto the tube and resumed ventilation.The patient had no return of spontaneous circulation, but the death was not a result of a device malfunction.
Additional Manufacturer Narrative
Correction: b1, b2, b3, b5, h1 and h6.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 55112-4391 ; 8006464633
• MDR Report Key: 23956555
• Report Number: 9681384-2026-00008
• Device Sequence Number: 14855638
• Product Code: BTR
• UDI-Device Identifier: 30884522000462
• UDI-Public: (01)30884522000462(17)300513(10)25E0044JZX
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K965132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 86450
• Device Catalogue Number: 86450
• Device Lot Number: 25E0044JZX
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 05/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES ON H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown