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

Model Number	86234
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the ventilator had a warning of loss pip and it was found that the endotracheal tube was disconnected from the jet adapter.At around 1230h, the tube disconnected again.After putting it back from "kcare" at 1445, the tube was disconnected more than four times.Between 1500h and 1600h, the tube was disconnected several more times while the patient settled in bed with the tube secured and appropriate boundaries in place.The patient desaturated into the 40's, the respiratory button was pushed, and the tube was reconnected to the ventilator.The patient went to 100% but then recovered to baseline.The patient was switched to conventional ventilation to prevent further disconnections of the ett.
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.

• 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: 20042869
• Report Number: 2936999-2024-01348
• Device Sequence Number: 12773546
• Product Code: BTR
• UDI-Device Identifier: 10884521797260
• UDI-Public: 10884521797260
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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 Expiration Date: 06/21/2022
• Device Model Number: 86234
• Device Catalogue Number: 86234
• 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: 08/02/2024
• Initial Report FDA Received Date: 08/22/2024
• 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: Required Intervention
• Patient Sex: Unknown