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

Model Number	6.0PELF
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tracheostomy tubes were associated with stoma irritation and did not last as expected, requiring replacement ap proximately every 2 weeks rather than the usual 4 weeks.Yellow discoloration was observed at the top of the tracheostomy.Secretions formed a barrier inside the tracheostomy and were not completely removed by suctioning.The patient experienced decreased oxygen levels, increased carbon dioxide levels, and near loss of consciousness.
Additional Manufacturer Narrative
D10 concomitant products: | 6.0pelf | 6.0pelf 6.0mm id paed l.| 25d0393jzx | | 6.0pelf | 6.0pelf 6.0mm id paed l.| 25d0393jzx | | 6.0pelf | 6.0pelf 6.0mm id paed l.| 25d0393jzx | | 6.0pelf | 6.0pelf 6.0mm id paed l.| 25d0393jzx | | 6.0pelf | 6.0pelf 6.0mm id paed l.| 25d0393jzx | | 6.0pelf | 6.0pelf 6.0mm id paed l.| 25d0393jzx |.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--439 ; +1(800)646-4633
• MDR Report Key: 50783445
• Report Number: 9681384-2026-00941
• Device Sequence Number: 18784521
• Product Code: JOH
• UDI-Device Identifier: 20884521779898
• UDI-Public: (01)20884521779898(17)300403(10)25D0393JZX
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 6.0PELF
• Device Catalogue Number: 6.0PELF
• Device Lot Number: 25D0393JZX
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 04/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES ON H11.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown