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

Model Number	86443
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Hypoventilation (1916); Unspecified Tissue Injury (4559); Unintended Extubation (4564)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: 86443, 86443-w 3.5mm inter hi-lo trach x10, (lot#: 24h1527jzx).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 the post-operative use of an intranasal 3.5 cuffed endotracheal tube (ett), the tube split when the respiratory therapist was placing the adapter to put the inline suction inline.This issue occurred twice, with the same problem arising after reintubation with another 3.5 endotracheal tube.Based on the report the patient had a serious harm.
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 the post-operative use of an intranasal 3.5 cuffed endotracheal tube (ett), the tube split when the respiratory therapist was placing the adapter to put the inline suction inline.Spo2 was maintained in the upper 90's during the event but had hypoventilation.This issue occurred twice, with the same problem arising after reintubation with another 3.5 endotracheal tube.Replacement of thee tube was done.The patient recover without other device related issues.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21176480
• Report Number: 9681384-2025-00062
• Device Sequence Number: 8538014
• Product Code: BTR
• UDI-Device Identifier: 30884522005696
• UDI-Public: 30884522005696
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 86443
• Device Catalogue Number: 86443
• Device Lot Number: 24H1527JZX
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/13/2025
• Date Device Manufactured: 08/30/2024
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 5 MO
• Patient Sex: Unknown