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

Model Number	18875
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the patient developed weak breathing due to intracerebral hemorrhage, endotracheal intubation was ordered by the physician and the intubation was successful.After intubation, the patient was connected to a ventilator for assisted breathing, but the ventilator issued a continuous low-pressure alarm.The alarm persisted even after repeated adjustments, the cuff pressure of the tube was checked and found to be slightly low, then the cuff was inflated.After inflation, the ventilator alarm disappeared then about 2 minutes later, the ventilator again issued a low-pressure alarm, which happened repeatedly.The tube was replaced, and when the removed tube was inspected, it inflated smoothly and the cuff was full.After water was injected into the cuff, continuous water jets were observed from the cuff wall, confirming cuff leakage.The event delayed the patient¿s treatment but no apparent harm.
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: 50184595
• Report Number: 9681384-2026-00791
• Device Sequence Number: 13286844
• Product Code: BTR
• UDI-Device Identifier: 40884521032539
• UDI-Public: (01)40884521032539(17)300626(10)25F1288JZX
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 18875
• Device Catalogue Number: 18875
• Device Lot Number: 25F1288JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/08/2026
• Date Device Manufactured: 06/26/2025
• 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: Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Unknown