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

Model Number	5.0PEF
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unintended Extubation (4564)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tracheostomy tube's flanges always break at the point where the neck strap was attached.One eyelet was completely broken, always on the side where traction is applied.The second eyelet was cracked.The tubes were replaced.
Additional Manufacturer Narrative
D10 concomitant product: 5.0pef, 5.0pef 5.0mm id paed med cuffless x1, lot # 24j1009jzx.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
Additional information: d9, g3, h3 and h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that both eyelets are broken.It was reported that the tracheostomy tube's flanges always break at the point where the neck strap was attached.One eyelet was completely broken, always on the side where traction is applied.The second eyelet was cracked.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.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: attach the neck strap to the flange eyelet.Flex the patient¿s neck forward and tie the neck strap.When properly adjusted, one finger space between the neck strap and the patient¿s neck should exist.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 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 55112-4391 ; 8006464633
• MDR Report Key: 24126216
• Report Number: 9681384-2026-00118
• Device Sequence Number: 9335199
• Product Code: JOH
• UDI-Device Identifier: 20884521779799
• UDI-Public: (01)20884521779799(17)291024(10)24J1007JZX
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5.0PEF
• Device Catalogue Number: 5.0PEF
• Device Lot Number: 24J1007JZX
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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
• Patient Age: 3 YR
• Patient Sex: Unknown
• Patient Weight: 14 KG