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

Model Number	3.5PEF
Medical Device Problem Codes	Material Separation (1562); Connection Problem (2900)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Unspecified Tissue Injury (4559)
Date of Event	04/06/2025
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 patient suffered an inner shaft or cannula breakage at home and needed to go to the or for retrieval.The broken cannula was removed from the left mainstem.
Additional Manufacturer Narrative
Additional information: a2, a3, a4, b3, b5, d3, d4, g3 and 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 patient's mother found the tracheotomy tube dislodged and was unable to locate the inner cannula, but was able to reinsert new trach without any issues.The patient started to present with bloody stools throughout the day and became concerned that the patient swallowed the inner cannula and was causing damage to the gi tract.The patient had to be taken to the operating room to have the inner cannula retrieved from the left mainstem.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the tube appeared to be broken from the flange.It was reported that the patient's mother found the tracheotomy tube dislodged and was unable to locate the inner cannula, but was able to reinsert new trach without any issues.The reported issue could be 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: capping or plugging the tube is not recommended because there may not be sufficient airway for the patient to breathe.The tube and accessories are supplied sterile and cannot be adequately resterilized for safe reuse and are intended for single patient use.The tube and accessories are for single use and single patient use only.Attempts to resterilize the tube and accessories may result in product failure and increased risk to the patient.The tube and obturator are for single patient use.Duration should not exceed twenty-nine (29) days.Covidien has not substantiated use of these devices beyond 29 days.Decisions about tracheostomy tube changes should be made by the responsible physician or designate using accepted medical techniques and judgement.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 32590 ; MX 32590
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32590 ; MX 32590
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21943536
• Report Number: 2936999-2025-00226
• Device Sequence Number: 12899971
• Product Code: JOH
• UDI-Device Identifier: 20884521101569
• UDI-Public: 20884521101569
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2025

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: 3.5PEF
• Device Catalogue Number: 3.5PEF
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 07/16/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/14/2025; 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization
• Patient Age: 5 YR
• Patient Sex: Unknown
• Patient Weight: 13 KG