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

Model Number	4.0PEF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during use, the tracheostomy tube was tear and cut from the tube base as shown in the attached image.The tube was replaced.
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 had tear and cut from the tube base as shown in the attached image.The tube was replaced.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Correction: b5.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the tube was broken, presented a discoloration and its texture was stiff.A dimensional test was performed on inner and outer diameter of the cannula and found within specifications.It was reported that the tracheostomy tube had tear and cut from the tube base.The reported issues were confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: capping or plugging the tube is not recommended because there may not be sufficient airway for the patient to breathe.The tube and accessories are supplied sterile and cannot be adequately re-sterilized for safe reuse and are intended for single patient use.The tube and accessories are for single use and single patient use only.Attempts to re-sterilize the tube and accessories may result in product failure and increased risk to the patient.The tube and obturator are for single patient use.Duration should not exceed twenty-nine (29) days.Covidien has not substantiated use of these devices beyond 29 days.Decisions about tracheostomy tube changes should be made by the responsible physician or designate using accepted medical techniques and judgement.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.
Additional Manufacturer Narrative
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, presented a discoloration and its texture was stiff.Functional testing found that the outer and inner diameters of the cannula were within specification.It was reported that the tracheostomy tube had tear and cut from the tube base.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.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: capping or plugging the tube is not recommended because there may not be sufficient airway for the patient to breathe.The tube and accessories are supplied sterile and cannot be adequately re-sterilized for safe reuse and are intended for single patient use.The tube and accessories are for single use and single patient use only attempts to re-sterilized the tube and accessories may result in product failure and increased risk to the patient.The tube and obturator are for single patient use.Duration should not exceed twenty-nine (29) days.Covidien has not substantiated use of these devices beyond 29 days.Decisions about tracheostomy tube changes should be made by the responsible physician or designate using accepted medical techniques and judgement.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 had tear and cut from the tube base as shown in the attached image.The tube was replaced.Additional information received, the broken cannula was placed at the end of (b)(6) 2024.It was rotated with several cannulas, and the usage time must be less than 2 months and carefully followed the maintenance instructions.

• 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: 20236645
• Report Number: 2936999-2024-01484
• Device Sequence Number: 15476214
• Product Code: JOH
• UDI-Device Identifier: 20884521779775
• UDI-Public: 20884521779775
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K182861
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2024

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: 4.0PEF
• Device Catalogue Number: 4.0PEF
• Device Lot Number: 23C1240JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 11/11/2024; 12/10/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/13/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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 Sex: Unknown