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

Model Number	8CN85A
Medical Device Problem Codes	Defective Component (2292); Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Hypoventilation (1916); Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
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 the additional air was inflated into the cuff of the tracheostomy tube, and it did get in.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b2, b3, b5, e1 (first name, last name, phone number), e4 (email), g3, h1, 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.
Event or Problem Description
It was reported that the cuff of the first tracheostomy tube did not work after 48 hours of being use.The patient could not be properly ventilated because of the issue despite the pilot balloon filled with air.The tube was replaced.Later at night, the second tube appeared to have a blockage in the air tube between the pilot line and the tracheostomy cuff balloon.Once a guide wire was passed through the air tube into the tracheostomy cuff to release the obstruction the cuff was then inflatable.But, due to continuous cuff leakage the tube was replaced with different tube.
Additional Manufacturer Narrative
Correction: h6, to add fdp (extubate) and imf (additional device required) 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: 24185662
• Report Number: 9681384-2026-00155
• Device Sequence Number: 21219968
• Product Code: JOH
• UDI-Device Identifier: 10884521172494
• UDI-Public: (01)10884521172494(17)280622(10)23F0605JZX(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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: 8CN85A
• Device Catalogue Number: 8CN85A
• Device Lot Number: 23F0605JZX
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/02/2026; 03/13/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/12/2026; 03/16/2026
• Date Device Manufactured: 06/22/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown