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

Model Number	SSVO
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
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 oxygen inlet cap of the speaking valve was loosed and detached easily when the patient coughed and during valve development.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Video analysis noted that the cap of the valve was attached and detached intentionally, and it appeared to be easy.It was reported that the oxygen inlet cap of the speaking valve was loosed and detached easily when the patient coughed and during valve development.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.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.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the oxygen inlet cap of the speaking valve was loosed and detached easily when the patient coughed and during valve development.The reported issues could not be confirmed.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.The instructions included with this device provide the following guidance: use the shiley speaking valve only with a cuffless tracheostomy tube or a fenestrated (either cuffed or cuffless) tracheostomy tube.If a fenestrated cuffed tube is used, the cuff must always be deflated.When a cuffed fenestrated or cuffless fenestrated tube is used, it is also recommended that the inner cannula, if used, be fenestrated.To provide supplemental oxygen when the oxygen port is present, remove the oxygen port cap and connect oxygen line.Retain the cap to prevent air bypass when the oxygen or humidification devices are not connected.The shiley speaking valve should be replaced after 29 days of normal use.Replace the shiley speaking valve should the flexible diaphragm become damaged or sticky or malfunction in any way.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
Additional information: g3, h3, evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.A video was also provided.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the oxygen inlet cap of the speaking valve was loosed and detached easily when the patient coughed and during valve development.The reported issue could not be confirmed.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.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: use the shiley speaking valve only with a cuffless tracheostomy tube or a fenestrated (either cuffed or cuffless) tracheostomy tube.If a fenestrated cuffed tube is used, the cuff must always be deflated.When a cuffed fenestrated or cuffless fenestrated tube is used, it is also recommended that the inner cannula, if used, be fenestrated.To provide supplemental oxygen when the oxygen port is present, remove the oxygen port cap and connect oxygen line.Retain the cap to prevent air bypass when the oxygen or humidification devices are not connected.The shiley speaking valve should be replaced after 29 days of normal use.Replace the shiley speaking valve should the flexible diaphragm become damaged or sticky or malfunction in any way.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 (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: 19542649
• Report Number: 2936999-2024-00916
• Device Sequence Number: 18036106
• Product Code: BTO
• UDI-Device Identifier: 40884522005372
• UDI-Public: 40884522005372
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K945407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/02/2025

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: SSVO
• Device Catalogue Number: SSVO
• Device Lot Number: 23F0309JZX
• 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: 05/18/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 03/14/2025; 04/02/2025
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 10/07/2024; 03/14/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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 Age: 24 MO
• Patient Sex: Female