MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	6CN75R
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Asystole (4442); Unintended Extubation (4564)
Date of Event	06/11/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient had cardiorespiratory arrest after not being able to ventilate through the tracheostomy and expired.During placement of the tracheostomy tube, it became angled, which made ventilation impossible.The patient was not on mechanical ventilation at that time.The patient was being assisted with an ambu bag.After ten minutes of ventilatory difficulty, the tube was replaced with similar issues.
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 TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer (Section G): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25635107
• Report Number: 8020889-2026-00198
• Device Sequence Number: 9552741
• Product Code: JOH
• UDI-Device Identifier: 10884521205437
• UDI-Public: (01)10884521205437(17)300401(10)202504421X(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K150844
• 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
• Report Date (Section B): 06/26/2026

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: 6CN75R
• Device Catalogue Number: 6CN75R
• Device Lot Number: 202504421X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/26/2026
• Date Device Manufactured: 04/28/2025
• 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: Death
• Patient Sex: Unknown