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

Model Number	86233
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: cap, cap cap for use with fenestrated i x10 (lot # unknown) 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.
Event or Problem Description
According to the reporter, during use, the cap of the endotracheal tube kept popping off when on a patient.The tube was replaced and worked.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that four samples were received for evaluation.All the samples were sealed inside their pouches.The lot numbers of the tubes were three samples of lot 23b1186jzx, and one sample of lot 24e1134jzx.It was observed that none of the tubes have the connector attached, although the connectors were present inside the pouches.The insertion mark of the connector in the proximal end was out of specification.A dimensional test was performed, and the inner and outer diameter of the tubes and the connectors were measured.It was reported that the cap of the endotracheal tube kept popping off when on a patient.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.The instructions included with this device provide the following guidance: the 15 mm connector is seated so that it can be removed with effort if cutting of the tube is desired.Follow the instructions if cutting is considered.Do not use lubricating jelly to ease connector reinsertion, as it may contribute to accidental disconnection.If shortening of the endotracheal tube is needed, use medical judgment to determine the appropriate tube length for each individual patient.Before intubating the patient, cut the tube, reinsert the 15 mm connector, and verify the connector is firmly seated in the tracheal tube.If the device is damaged or the integrity of the sterile barrier has been compromised, do not use the product and contact your covidien representative for further information.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20571554
• Report Number: 9681384-2024-00107
• Device Sequence Number: 12900508
• Product Code: BTR
• UDI-Device Identifier: 10884521797253
• UDI-Public: 10884521797253
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 86233
• Device Catalogue Number: 86233
• Device Lot Number: 23B1186JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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.
• Patient Sex: Unknown