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

Model Number	86451
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	08/24/2024
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, during use, the tracheostomy tube's cuff had leaks.The tube was replaced.
Additional Manufacturer Narrative
Additional information: b5, b7, g3, h6.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 arrived by emergency medical services.The patient had multi system level 1 trauma alert as the status post motor vehicle collision.The patient had multiple fractures.It was an emergent situation in which the patient was unresponsive and there was obstruction by edema and blood.Neck mobility was reduced, and c collar was present.During primary, there was concern for airway compromise.There was bvm (bag valve mask) ventilations, and the patient was prepped for rsi (rapid sequenceintubation) with etomidate and succ.The patient was reoxygenated and intubated with an ett (endotracheal tube) at 24 cm at the teeth with a video assisted, hypercurved laryngoscope blade.No bougie was used.It was grade view iii in which the tube was visualized through the cords.The tube was secured with an ett holder and patient had positive color change and bilateral breath sounds, absent over epigastrium and equal.The patient was 94% on ventilator.Placement verification was done with colorimetric end tidal co2 (etco2), cxr (chest x ray) verification, direct visualization, equal breath sounds and tube exhalation.A portable cxr noted the ett was high.It was advanced 4 cm by the rt (respiratory therapist) and the procedure was tolerated.There was a concern for a cuff leak.The patient was sedated on propofol and rocuronium 100 mg was administered for rsi.A bougie assisted hypercurved wire tube exchange was performed with a 8.0mm cuffed ett at 27 cm at the teeth.It was secured with an ett holder.The placement was verified with positive colorimetric etco2 change, cxr verification, direct visualization, bilateral and equal breath sounds and tube exhalation.The cxr found that the tube had the appropriate position.The patient tolerated well with no immediate complications.There was bvm (bag valve mask) ventilations to ct.An orogastric tube #16 was placed.The patient was noted to be in the intensive care unit.

• 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: 20186003
• Report Number: 2936999-2024-01434
• Device Sequence Number: 20907390
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 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: 08/27/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/08/2024
• 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
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 103 KG