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

Model Number	86114
Medical Device Problem Codes	Use of Device Problem (1670); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the endotracheal tube's pilot valve required a lot of air (pressure) to be fully inflated, it was not possible to confirm the cuff pressure when cuff was inflated and the cuff was deformed upon inflation before use.There was no patient involvement.
Additional Manufacturer Narrative
D10 concomitant product: 86113 - 86613 us 8.0mm hi-lo ett x10, lot# 21l0623jzx 86113 - 86613 us 8.0mm hi-lo ett x10, lot# 21l0623jzx 86113 - 86613 us 8.0mm hi-lo ett x10, lot# 21l0623jzx.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 endotracheal tube's cuff required a lot of air (pressure) to be fully inflated, it was not possible to confirm the cuff pressure when cuff was inflated and the cuff was deformed upon inflation before use.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that all the components were assembled properly at the tube.Functionally, an inflation/deflation test was performed 25cc of air was applied to the cuff using a syringe and it was observed the cuff shape is distorted, the sample was left inflated 2 hours.It was reported that there was cuff inflation/ deflation issue.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: do not overinflate cuff.Ordinarily, the cuff pressure should not exceed 25 cm h2o.Maintaining a seal pressure at or below 25 cm h2o.Over-inflation can result in tracheal damage, rupture of the cuff with subsequent deflation, or in cuff distortion which may lead to airway blockage.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, 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: 17283266
• Report Number: 2936999-2023-00556
• Device Sequence Number: 14208821
• Product Code: BTR
• UDI-Device Identifier: 10884522000147
• UDI-Public: 10884522000147
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: 86114
• Device Catalogue Number: 86114
• Device Lot Number: 23A0894JZX
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Sex: Unknown