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

Model Number	18775S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, when an attempt was made to extubate the patient one day after starting ope, the air was removed, but the pilot balloon did not deflate.Apparently, the patient was extubated as it was because it was unclear whether the air in the cuff had escaped.The tube was not 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.
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.The stylet was re ceived as well.The device was received outside its pouch.Visual inspection noted that the inflation line reached the pvt valve, which resulted in the balloon not deflating.Functionally, an inflation/deflation test was performed.Air was applied to the cuff usin g a syringe connected to the inflation line and it was observed that the cuff held the air.The sample was left inflated for 2 hours, and no leaks were observed during the test.Additionally, the sample was submerged into a container filled with water and no leaks were observed.The pilot balloon was tested, and it was noticed that air could be pumped in and out with no difficulty.However, at the time of deflation, the pilot balloon did not deflate.It was reported that the air was removed, but the pilot balloon did not deflate.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.This issue may occur due to an excessive insertion of the inflation line and improper visual inspection.Internal process improvements have been initiated to mitigate this issue.The instructions included with this device provide the following guidance: test the cuff, pilot balloon and valve for integrity by inflation prior to use.Insert a luer tip syringe into the cuff inflation valve housing and inject enough air to fully inflate cuff.After test inflation, completely evacuate the air.Check to verify that cuff inflation system is not leaking.Integrity of the system should be verified periodically during the intubation period.Any deviation from the selected seal pressure should be investigated and corrected immediately.Each tube¿s cuff, pilot balloon and valve should be tested by inflation prior to use.If dysfunction is detected in any part of the inflation system, the tube should not be used and be returned.Do not overinflate the cuff.Ordinarily, the cuff pressure should not exceed 25 cmh2o.Overinflation can result in tracheal damage, rupture of the cuff with subsequent deflation, or in cuff distortion which may lead to airway blockage.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: TAPERGUARD
• 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: 19316215
• Report Number: 2936999-2024-00766
• Device Sequence Number: 7577752
• Product Code: BTR
• UDI-Device Identifier: 10884521103856
• UDI-Public: 10884521103856
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090352
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 18775S
• Device Catalogue Number: 18775S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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
• Patient Sex: Unknown