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

Model Number	87480
Medical Device Problem Codes	Obstruction of Flow (2423); Material Deformation (2976)
Health Effect - Clinical Codes	Hypoventilation (1916); Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	02/03/2026
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 post-operatively, while patient was still under mechanical ventilation, airway emergency developed due to airway obstruction in endotracheal tube with inability to pass bronchoscopy through tube without foreign body obstruction.During the vid eolaryngoscopy, it was revealed a kink on the tube at the level of the oropharynx, at 17 cm marking with patient having difficult ventilation with tidal volume only 60-80 ml and desaturation occurred.Kinking was spontaneous, with no surrounding tissue swelling and adequate space around tube.Kinking remained despite manipulation and necessitated change of endo-tracheal tube.After exchange of tube, examination of the kinked tube revealed soft texture, easily compressed and kinked by manual manipulation.
Additional Manufacturer Narrative
Additional information: initial reporter and g3.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that a kink on the tube at the level of the oropharynx , at 17 cm marking with patient having difficult ventilation with tidal volume only 60-80 ml and desaturation occurred.Kinking was spontaneous, with no surrounding tissue swelling and adequate space around tube.Kinking remained despite manipulation and necessitated change of endo-tracheal tube.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: 24510066
• Report Number: 9681384-2026-00271
• Device Sequence Number: 10440735
• Product Code: BTR
• UDI-Device Identifier: 10884521815285
• UDI-Public: (01)10884521815285(17)300813(10)25H0257JZX(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2026

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: 87480
• Device Catalogue Number: 87480
• Device Lot Number: 25H0257JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 05/22/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/23/2026; 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown