MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	UNKNOWN - SHILEY
Medical Device Problem Codes	Defective Component (2292); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Hypoventilation (1916); Stenosis (2263); Low Oxygen Saturation (2477)
Date of Event	05/04/2025
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 a cuffed tracheostomy tube was then inserted into the trachea, the balloon was inflated, and the circuit was connected.There was positive end-tidal co2.It was noted shortly thereafter that the patient was not achieving adequate tidal volumes on the vent and began desaturating to low 80's.The patient was branched promptly via the tracheostomy and it was noted that the inflated cuff was extending distal to the end of the tube, producing severe stenosis of the opening of the tracheostomy tube.The balloon was partially deflated and the occlusion problem was resolved as seen on bronchoscopy.At this time, the patients end title, tidal volumes, and saturation all normalized.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6, fdp code (stenosis).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): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22350049
• Report Number: 2936999-2025-00356
• Device Sequence Number: 15583428
• Product Code: JOH
• UDI-Device Identifier: 10884521133136
• UDI-Public: 10884521133136
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: UNKNOWN - SHILEY
• Device Catalogue Number: UNKNOWN - SHILEY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/22/2025
• 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: Life Threatening; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Unknown
• Patient Weight: 117 KG
• Patient Ethnicity: Hispanic