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

Model Number	86444
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Bradycardia (1751); Hemorrhage/Blood Loss/Bleeding (1888); Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	06/08/2024
Type of Reportable Event	Serious Injury
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, intra-operatively, there was difficulty passing a suction catheter through the endotracheal tube of a pediatric intensive care unit (icu) patient.Initially attempted multiple non-invasive interventions had no improvement.The decision was made to perform videolaryngoscopy to view the tube and changed.On visualization, the tube was noted to have significant kink, and during exchange, the patient experienced significant desaturations and drop in heart rate that required medications to prevent progression of possible brady cardiac arrest.The patient also required significant suctioning and some airway trauma during the exchange leading to bloody secretions and a subsequent drop in hemoglobin.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was difficulty passing a suction catheter through the endotracheal tube of a pediatric icu patient.Initially, attempted multiple non-invasive interventions had no improvement.The decision was made to perform video laryngoscopy to view the tube and changed.On visualization, the tube was noted to have significant kink, and during exchange, the patient experienced significant desaturations and drop in heart rate that required medications to prevent progression of possible brady cardiac arrest.The patient also required significant suctioning and some airway trauma during the exchange leading to bloody secretions and a subsequent drop in hemoglobin.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: 20494478
• Report Number: 2936999-2024-01630
• Device Sequence Number: 4174442
• Product Code: BTR
• UDI-Device Identifier: 20884522005705
• UDI-Public: 20884522005705
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: 86444
• Device Catalogue Number: 86444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Other
• Patient Age: 11 MO
• Patient Sex: Female