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

Model Number	5CN70H
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 7un80h 8.0mm shiley cuffless trach ca (lot#: unknown); 7un80h 8.0mm shiley cuffless trach ca (lot#: unknown); 7un80h 8.0mm shiley cuffless trach ca (lot#: unknown); 7un80h 8.0mm shiley cuffless trach ca (lot#: unknown); medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient required five trach changes in seven days, and upon inspection the tracheostomy tube's cuff was leaking at the point where the pilot balloon line entered the cuff during use.The first one failed after 12 hours, the second after less than 2 hours and the leak was at the same place.The trach was changed from a 7.5 to a 7.0 after the third event.The fourth tube leaked in less than 4 hours and the fifth leaked in less than 2 hours.
Additional Manufacturer Narrative
Additional information: d4 (model #, catalog#, udi), d9, g3, h3, h6 d10 concomitant product: 5cn70h, 7.0mm shil cuffed trach cann (lot#: unknown); 6cn75h, 7.5mm shil cuffed trach cann (lot#: 2010019jzx); 6cn75h, 7.5mm shil cuffed trach cann (lot#: 21i0631jzx); 6cn75h, 7.5mm shil cuffed trach cann (lot#: 23e0412jzx).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the cuff presents a small cut near the proximal shoulder.Functionally, an inflation/deflation test was performed using a syringe.13cc of air was applied to the cuff and it was observed the cuff deflated after few seconds.It was reported that there was a cut in cuff.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the cuff had contact with sharp tools/surface/bone anatomical structure.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: ordinarily, cuff pressure should not exceed 25 cm of h2o.Over-inflation of the cuff may cause tracheal damage and may inhibit ventilation.Consult with the attending physician.Test each tube¿s cuff, pilot balloon, and valve by inflation prior to use.If dysfunction is detected in any part of the inflation system, the tube should not be used.Cuff inflation should be checked on a regular basis, and replacement tracheostomy tubes should be kept at bedside.To ease placement of the tracheostomy tube, generously lubricate the surface of the loading dilator.To ease insertion and to guard against cuff perforation from sharp edges of cartilage, taper back the cuff by deflating the cuff and gently moving it away from the distal tip of the cannula toward the neck plate as the residual air is removed by deflation.When tapering the cuff, do not use sharp instruments that would damage the cuff, such as forceps or hemostats.Extremes of movement may result in mucosal abrasion and transient disruption of cuff seal.The use of lidocaine topical aerosol has been associated with the formation of pin holes in pvc cuffs.Lidocaine hydrochloride solution has been reported not to have this effect.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 17786188
• Report Number: 2936999-2023-00813
• Device Sequence Number: 7433725
• Product Code: JOH
• UDI-Device Identifier: 20884521176314
• UDI-Public: 20884521176314
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K142296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2024

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: 5CN70H
• Device Catalogue Number: 5CN70H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/09/2023; 03/04/2024
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/27/2023; 03/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTE ON H10.; SEE NOTE ON H10.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG