MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	87480
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
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 during use of the endotracheal tube, a cuff leak was identified.During ventilation, abnormal air leakage was observed when 6 ml of air was inflated into the cuff.Additional inflation up to 10 ml and tube position reassessment were performed, but the abnormal leak persisted.The endotracheal tube was removed and replaced with a new one, and the procedure was subsequently terminated.Post-procedure testing of the removed tube revealed cuff leakage, as demonstrated in a video.
Additional Manufacturer Narrative
Additional information: d9, g3, h3.H6, h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.A video was also provided.Visual inspection noted that the cuff presented two cuts, which were measured 0.5185 and 0.2735 inches.An in flation/deflation test was performed 25cc of air was applied to the cuff using a syringe and it was observed the cuff deflated immediately.It can be observed on the video that the endotracheal tube was intended to be inflated with air by the physician in a container with water and a leak occurs during the inspection.It was reported that during use of the endotracheal tube, a cuff leak was identified.The reported issue was confirmed.The most likely cause was unintended use error caused or contributed to event.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: do not overinflate the cuff.It is recommended that the cuff pressure should not exceed 25cmh2o.Overinflation can result in tracheal damage, rupture of the cuff with subsequent deflation, or in cuff distortion which may lead to airway blockage.Test the cuff, pilot balloon and valve for integrity by inflation prior to use.Insert a luer tip syringe into the cuff inflation valve housing and inject enough air to fully inflate cuff.After test inflation, completely evacuate the air.Various bony anatomical structures (e.G., teeth, turbinates) within the airway or any intubation tools with sharp surfaces might jeopardize cuff integrity.Damage to the thin-walled cuff during insertion will subject the patient to the risk of extubation and reintubation.If the cuff is damaged, the tube should not be used.Deflate the cuff prior to repositioning the tube.Movement of the tube with the cuff inflated could result in patient injury, requiring possible medical intervention or damage to the cuff.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, TRACHEAL (W/WO CONNECTOR)
• 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: 23038735
• Report Number: 9681384-2025-00990
• Device Sequence Number: 18677605
• Product Code: BTR
• UDI-Device Identifier: 10884521815285
• UDI-Public: (01)10884521815285(17)300312(10)25C0553JZX(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K233341
• 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): 11/20/2025

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: 87480
• Device Catalogue Number: 87480
• Device Lot Number: 25C0553JZX
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 78 KG