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

Model Number	4.0PCF
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	07/11/2025
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 a hospital procedure, the cannula was new and checked before use by filling it with 4ml of air and emptying it back.A mini drop of optilube gel was added to the cannula and was placed, the mandrain was removed, ventilation was placed and balloon was filled with 2ml of air and after a short pause again with 2ml of air, making a total of 4ml but a cuff inflation/deflation occurred.The tube was replaced.
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.An i nflation/deflation test was performed 1.5 cc of air was applied to the cuff using a syringe and it was observed the cuff presents a distortion, but no leaks were observed.It was reported that the cannula was new and checked before use by filling it with 4ml of air and emptying it back.A mini drop of optilube gel was added to the cannula and was placed, the mandrain was removed, ventilation was placed and balloon was filled with 2ml of air and after a short pause again with 2ml of air, making a total of 4ml but a cuff inflation/deflation occurred.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: do not use larger than a 1.0 cc/ml syringe when adding air into the cuff and monitor the cuff pressures frequently.Do not overinflate the cuff.Ordinarily, cuff pressure should not exceed 25 cm of h2o.Closely monitor cuff pressure under a physician¿s guidance.Overinflation may lead to permanent tracheal damage, rupture of the cuff with subsequent deflation, or cuff distortion that may cause airway blockage.Prior to use, test the cuff, pilot balloon and valve for integrity.Inflate the cuff with a volume of air indicated in table 1.Observe for deflation over time (2 - 10 minutes) or immerse the tube in sterile saline for a minimum of 10 seconds and observe for air leakage.After test inflation, completely evacuate the air.If any leakage is noted, do not use the tube and obtain a new one.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
Correction: a4 additional information: g3 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.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: 22635606
• Report Number: 9681384-2025-00809
• Device Sequence Number: 21083304
• Product Code: JOH
• UDI-Device Identifier: 10884521103535
• UDI-Public: 10884521103535
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 09/10/2025

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: 4.0PCF
• Device Catalogue Number: 4.0PCF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 09/05/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/27/2025; 09/10/2025
• 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
• Patient Age: 11 MO
• Patient Sex: Unknown
• Patient Weight: 8 KG