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

Model Number	7UN80A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during use, the patient had a pain complaint in the trachea.The tracheostomy tube's cannula was found longer than the tube.
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.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.A functional test was performed inner cannula was inserted into the outer cannula and the inner cannula protruded out of the outer cannula and this protrusion was out of tolerance.It was reported that the tracheostomy tube's cannula was found longer than the tube.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: use the 15mm cap only with the shiley cuffless fenestrated, cuffless, fenestrated low pressure cuffed, disposable cannula cuffless, disposable cannula cuffless fenestrated, as well as the shiley pediatric and neonatal tracheostomy tubes.Prior to attaching the 15mm cap make sure that the fenestration(s) are not occluded, the cuff is completely deflated and that there is sufficient airway for the patient.Verify that the 15mm cap is attached securely after each use.If parts become worn or loose, immediately report this to your physician for prompt replacement of the tracheostomy tube.Remove the 15mm cap immediately if the patient has difficulty breathing.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20642055
• Report Number: 9681384-2024-00123
• Device Sequence Number: 18014554
• Product Code: JOH
• UDI-Device Identifier: 20884521175737
• UDI-Public: 20884521175737
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 7UN80A
• Device Catalogue Number: 7UN80A
• Device Lot Number: 23I0447JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• 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: Other
• Patient Sex: Unknown