MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) TAPERGUARD; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	18775S
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at 11:00 am, the patient on warfarin, who experienced heavy bleeding from broken teeth, was prepared for transfer to another hospital.During repositioning, multiple attempts were made to reinsert the tube due to visibility issues and cuff leaks.The first two 8.0 endotracheal tubes passed leak tests, but after repositioning the patient laterally, it was found that the cuff had a leak and was deflated.A 7.5 tube was used and passed leak test; after repositioning the patient laterally, the doctor check the lung and a leak sound was heard again.It was found that the cuff of the 7.5 tube was broken.A fourth tube (size 7.5) was tested, showed no leakage, and remained functional, allowing the patient to be successfully referred.
Additional Manufacturer Narrative
D10 concomitant products: 18780s, 18780s 8.0mm taperguard w stylet x10, (lot# 25g1231jzx) 18780s, 18780s 8.0mm taperguard w stylet x10, (lot# 25g1231jzx).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 and a photo were available for evaluation.Visual inspection noted that the cuff was deflated and it appears that the cuff has a tear.It was reported that that the cuff had a leak and was deflated.The reported issue was confirmed.The most likely cause was as unintended use error caused or contributed to event.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: 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 should 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.Deflate the cuff prior to repositioning the tube.Movement of the tube with the cuff inflated could result in patient injury, requiring possible medical intervention or damage to the cuff.Various bony anatomical structures (e.G., teeth, turbinates) within the airway or any intubation tools with sharp surfaces might jeopardize cuff integrity.Damage to the thin-walled cuff during insertion will subject the patient to the risk of extubation and re-intubation.If the cuff is damaged, the tube should not be used.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): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23700785
• Report Number: 9681384-2025-01281
• Device Sequence Number: 10670572
• Product Code: BTR
• UDI-Device Identifier: 10884521620193
• UDI-Public: (01)10884521620193(17)291017(10)24J0162JZX
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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
• Device Lot Number: 24J0162JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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 H11.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 65 KG