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

Model Number	86451
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pneumonia (2011); Overinflation of Lung (2397); Unintended Extubation (4564)
Date of Event	08/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: unkett, unspecified endotrach tube, 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, the patient using the tube experienced hyper expansion and developed right lower lobe pneumonia.The patient was found obtunded, and rapid sequence intubation was performed.Post-intubation, the patient experienced hypotension and was given a 1l bolus crystalloid and push dose epinephrine, which improved the pressure.However, potassium levels spiked to 6.0, and albuterol was administered for an hour.Subsequently, the cuff leaked, and the tube was dislodged during icu admission.The tube was replaced, but the patient experienced post-intubation hypotension again and peripheral norepinephrine drops was started.
Additional Manufacturer Narrative
Additional information: b5, b7, g3, h6, h10.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, the patient was provided propofol (bolus 100mg) and reintubated with the tube at 24 cm at the teeth and with pulse oxygenation of 85% at the time.A chest x ray noted hyper expansion and developing right lower lobe pneumonia.The patient was found obtunded, and rapid sequence intubation was performed.Post-intubation, the patient experienced hypotension and was given a 1l bolus crystalloid and push dose epinephrine, which improved the pressure.However, potassium levels spiked to 6.0, and albuterol was administered for an hour.Subsequently, the cuff leaked, and the tube was dislodged during icu admission.The tube was replaced, but the patient experienced post-intubation hypotension again and peripheral norepinephrine drops was started.The patient and tolerated the procedure.The patient tested positive for covid 19.

• 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: 20481907
• Report Number: 2936999-2024-01622
• Device Sequence Number: 15543707
• Product Code: BTR
• UDI-Device Identifier: 30884522000479
• UDI-Public: 30884522000479
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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 Model Number: 86451
• Device Catalogue Number: 86451
• Device Lot Number: 24F1151JZX
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/21/2024
• Date Device Manufactured: 06/25/2024
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 98 KG