MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	9CN90A
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the safety balloon of the cannula had a leak because it was damaged, the patient began to desaturate up to 40%, and the recovery was prolonged.The first cannula was kept in place for 20 minutes to see if the issue could be resolved before it was removed.After being ineffective in retrieving patient oxygenation, the doctors take the initiative to remove the cannula and install a new one.When removing the cannula, the scrub nurse checked the conditions again.Of the cannula that was removed, and when revising the balloon, detects air leakage, and performs a test with the cannula submerged in solution, and noticed the significant leak of air with the balloon.There was no issue mentioned in the event about the second device.
Additional Manufacturer Narrative
D10 concomitant product: 9cn90a, 9cn90a 9.0mm trach tube w tg cuff x1, ( lot #23d0309jzx) 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 TRACHEOSTOMY AND TUBE CUFF
• 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: 22835979
• Report Number: 9681384-2025-00893
• Device Sequence Number: 9410205
• Product Code: JOH
• UDI-Device Identifier: 10884521172517
• UDI-Public: (01)10884521172517(17)280417(10)23D0309JZX(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K142296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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: 9CN90A
• Device Catalogue Number: 9CN90A
• Device Lot Number: 23D0309JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/18/2025
• Date Device Manufactured: 04/17/2023
• 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 H11
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 82 KG