MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	3.5PEF
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Respiratory Insufficiency (4462); Unintended Extubation (4564)
Date of Event	03/04/2024
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.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 presented stridor and respiratory distress, which became accentuated towards the entire week due to the tracheostomy's inner canula separated from the cannular tube based on the photo provided.The trach was replaced.
Additional Manufacturer Narrative
H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the tube was broken at the proximal end separating the flange-connector.A dimensional test was performed, the inner and outer diameter of the tube was within specification.During the test, it was noticed the tube presents a stiff texture.It was reported that the device's inner canula was separated from the cannular tube.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: prior to tube insertion, check that the obturator can be inserted and removed without difficulty.Do not use excessive force to connect accessories to the 15mmconnector.This may result in difficult disconnection.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 TRACHEOSTOMY AND TUBE CUFF
• 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: 19081464
• Report Number: 2936999-2024-00568
• Device Sequence Number: 8359114
• Product Code: JOH
• UDI-Device Identifier: 20884521779768
• UDI-Public: 20884521779768
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K122531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 3.5PEF
• Device Catalogue Number: 3.5PEF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 09/30/2024
• 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: Other; Required Intervention
• Patient Age: 7 YR
• Patient Sex: Male