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

Model Number	86444
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Unintended Extubation (4564)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an airway fire occurred in the oropharynx at the beginning of a tonsillectomy procedure.A flash of flame observed for a second.The oral cavity and pharynx were immediately irrigated with sterile saline, the endotracheal tube was removed, and the patient was reintubated and transferred for observation.It was reported that the patient had a serious injury.The patient was hospitalized as a result of the event.Bronchoscopy was performed at the bedside and showed no signs of edema, discoloration, or other signs of thermal injury.No deaths, infections, or other complications were reported.
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
Additional information: d9, 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 an endotracheal tube with the middle part like a burn condition.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that an airway fire occurred in the oropharynx at the beginning of a tonsillectomy procedure.A flash of flame observed for a second.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: use of hi-lo and intermediate hi-lo cuffed tracheal tubes in procedures which will involve the use of a laser or an electrosurgical active electrode in the immediate area of the device is contraindicated.Contact of the beam or electrode with the tracheal tube, especially in the presence of oxygen-enriched or nitrous oxide containing mixtures could result in the rapid combustion of the tube with harmful thermal effects and with emission of corrosive and toxic combustion products including hydrochloric acid (hcl).It has been reported by hirshman and smith that mixtures of nitrous oxide and oxygen support combustion about the same as pure oxygen and that in addition to ignition by direct contact with the beam, the interior of the tube can also be ignited by contact with flaming tissue in close proximity to the tip of the tracheal tube (hirshman, c.A.And smith, j.: indirect ignition of the endotracheal tube during carbon dioxide laser surgery.Arch otolaryngol vol.106: 639-641, 1980).As these devices may have been subjected to handling, storage conditions or preparation which compromised functional integrity; each tube¿s cuff, pilot balloon and valve should be tested by inflation prior to use.If dysfunction is detected in any part of the inflation system, the tube should not be used.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: 22630622
• Report Number: 9681384-2025-00806
• Device Sequence Number: 18140107
• Product Code: BTR
• UDI-Device Identifier: 20884522005705
• UDI-Public: (01)20884522005705(17)300219(10)25B1138JZX
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K965132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 86444
• Device Catalogue Number: 86444
• Device Lot Number: 25B1138JZX
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 3 YR
• Patient Sex: Unknown
• Patient Weight: 14 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White