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

Model Number	86112
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Hypoventilation (1916); Insufficient Information (4580)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was proned with 7.5 non evac tube at 23cm at the teeth.The depth had previously been confirmed via chest xray.Upon un-proning the patient there was air leaking from patient's mouth.When the cuff was checked, it was inflated but the patient still not getting enough volume from the ventilator.While bagging the patient, large amount of air escaping the patient's mouth was felt despite having an inflated cuff.When looking with a glide, the cuff appeared above the vocal cords despite showing tube was at the previous confirmed depth, then the physician used the bronchoscopy to make sure tube was still in the trachea.As the tube was still in the trachea, the cuff was deflated and tube was pushed in to 28cm at the lip.During bronchoscopy, it showed that the tube was still above the carina, the cuff was reinflated and the patient was then getting appropriate volumes on ventilator.
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: b2, b5, g3, h1 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 was proned with 7.5 non evac tube at 23cm at the teeth and the depth had previously been confirmed via chest xray.Upon un-proning the patient there was air leaking from patient's mouth and when the cuff was checked, it was inflated but the patient still not getting enough volume from the ventilator.The reduced ventilation volumes and drop in oxygen required additional bagging, while bagging the patient, large amount of air escaping the patient's mouth was felt despite having an inflated cuff.When looking with a glidescope, the cuff appeared above the vocal cords despite showing tube was at the previous confirmed depth, then the physician used bronchoscopy to make sure tube was still in the trachea.As the tube was still in the trachea, the cuff was deflated and tube was pushed in to 28cm at the lip.During bronchoscopy, it showed that the tube was still above the carina, the cuff was reinflated and the patient was then getting appropriate volumes on ventilator.

• 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: 25309168
• Report Number: 9681384-2026-00572
• Device Sequence Number: 9980987
• Product Code: BTR
• UDI-Device Identifier: 10884522000123
• UDI-Public: (01)10884522000123(17)290902(10)24I0020JZX
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: 86112
• Device Catalogue Number: 86112
• Device Lot Number: 24I0020JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 09/02/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown