MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	18750
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	05/25/2024
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
According to the reporter, post-operatively, the pilot line was off from the endotracheal tube.The replacement of the tube was done.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the inflation line was separated and the inflation line presented a lack of bonding agent.Additionally it was observed the distal end was missing the molding, murphy eye, the cuff and notches since the tube was cut and the distal end was not received.It was reported that the pilot line was off from the endotracheal tube.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: test the cuff, pilot balloon and valve for integrity by inflation prior to use.Insert a luer tip syringe into the cuff inflation valve housing and inject enough air to fully inflate cuff.After test inflation, completely evacuate the air.Check to verify that cuff inflation system is not leaking.Integrity of the system should be verified periodically during the intubation period.Any deviation from the selected seal pressure should be investigated and corrected immediately.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): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19684204
• Report Number: 2936999-2024-01041
• Device Sequence Number: 14237088
• Product Code: BTR
• UDI-Device Identifier: 60884522007530
• UDI-Public: 60884522007530
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K090352
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 18750
• Device Catalogue Number: 18750
• Device Lot Number: 23F1077JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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
• Patient Sex: Unknown