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

Model Number	87480
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that newer endotracheal tubes, particularly the 7.5 mm and 8.0 mm sizes, had an extremely loose tube-to-hub connection.The endotracheal tubes reportedly arrived from packaging with the hub loosely connected.During intraoperative use on a patient, the tube-to-hub connection may disconnect.Condensation within the tube reportedly prevented clinicians from advancing the hub further to achieve a tighter fit.A visual difference was observed between the prior and newer tube-to-hub connections, and it was alleged that the newer design may contribute to an insecure connection and potential disconnection during patient use.There was no patient outcome.
Additional Manufacturer Narrative
Concomitant product: 87475 87475 shiley oral nasal intermediate 7.5 lot number: unknown 86452 86452 8.0mm inter hi-lo trach x10 lot number: 25k0184jzx 86451 86451 7.5mm inter hi-lo trach x10 lot number: 25g0021jzx.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: 50667100
• Report Number: 9681384-2026-00869
• Device Sequence Number: 10153412
• Product Code: BTR
• UDI-Device Identifier: 10884521815285
• UDI-Public: (01)10884521815285(17)310407(10)26D0128JZX(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 87480
• Device Catalogue Number: 87480
• Device Lot Number: 26D0128JZX
• 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: 08/12/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 04/07/2026
• 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: PLEASE SEE NOTES ON H11.
• Patient Sex: Unknown