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

Model Number	3.5NCF
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 3.5ncf 3.5mm id neo sml cuffed x1 (lot#: 23a0177jzx).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 cuffs of the tracheostomy tube had an air leak.The pressure were check regularly but the pressure decreased by 5-10 cmh20 each time.Replacement of the tube done twice.
Event or Problem Description
According to the reporter, during use, the cuffs of the tracheostomy tubes had an air leak.The pressure were check regularly but the pressure decreased by 5-10 cmh20 each time.Replacement of the tube done twice.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.An inflation/defl ation test was performed using syringe, 1cc of air was applied and no leaks could be observed in the cuff nor inflation line, both samples were left inflated 24 hours and no leaks were observed.It was reported that the cuffs of the tracheostomy tubes had an air leak.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the syringe is kept connected to the pilot of one of the samples, since the pvt valve presents a small dent which leaks air while the syringe is connected to the inflation system.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: each tube¿s cuff, pilot balloon and valve should be tested by inflation prior to tube insertion.If dysfunction is detected in any part of the inflation system, the tube should not be used.Do not overinflate the cuff.Ordinarily, cuff pressure should not exceed 25 cm of h2o.Closely monitor cuff pressure under a physician¿s guidance.Overinflation may lead to permanent tracheal damage, rupture of the cuff with subsequent deflation, or cuff distortion that may cause airway blockage.To ease insertion and to guard against cuff perforation from sharp edges of cartilage, the cuff should be pulled back.Inflate the cuff and gently move the cuff away from the distal tip of the cannula towards the neck plate as the residual air is removed by deflation.Do not use sharp instruments such as forceps or hemostats that would damage the cuff when manipulating it.Consider the use of an appropriate sized syringe in the range of the leak test inflation volume for accurate and precise inflation.Remove the syringe from the valve after cuff inflation.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 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: 19174941
• Report Number: 2936999-2024-00673
• Device Sequence Number: 12717063
• Product Code: JOH
• UDI-Device Identifier: 20884521779553
• UDI-Public: 20884521779553
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: 3.5NCF
• Device Catalogue Number: 3.5NCF
• Device Lot Number: 23A0177JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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 NOTE ON H11
• Patient Sex: Unknown