MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,4.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10108
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "air gradually leaked from the cuff during use.Therefore, the tube was replaced with a new one to complete the procedure.Neither desaturation nor injury to the patient was reported".
Event or Problem Description
It was reported "air gradually leaked from the cuff during use.Therefore, the tube was replaced with a new one to complete the pro cedure.Neither desaturation nor injury to the patient was reported".
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10108 et tube, cf,4.0 for investigation.The et tube was visu-ally examined with and without magnification.Visual examination of the returned devices re-vealed that the samples appeared typical.No defects or anomalies were observed.Functional inspection was performed on the returned device to test for proper inflation and deflation.A lab inventory syringe was filled with air and attached to the pilot balloon.Upon injection of air, the balloon cuff was unable to stay inflated.The device was submerged underwater in order to test for leaks.Upon inflation, the device leaked from a small hole in the balloon cuff.Device history record investigation did not show issues related to complaint.The ifu for this product, was reviewed as a part of this complaint investigation.The ifu states, "the tracheal tube cuff inflation system, including the valve, should be checked prior to intubation.If a malfunction is detected in any part of the system, the tube should not be used." "care should be taken to avoid damaging the thin-walled cuffs during intubation.If cuff is damaged, the tube should not be used." the ifu also states, "cuff pressure should be monitored routinely to assure that an adequate tracheal seal is maintained and that the cuff has not become over-inflated.The tracheal tube cuff should be slowly inflated with the minimum amount of air required to provide an effective tracheal seal.Do not inflate with a measured volume of air or by "feel" of pressure in the syringe since little resistance should be felt during inflation.The reported complaint of "leak - device leak - cuff" was confirmed based upon the sample received.The sample was found to have a small hole in the balloon cuff which prevented it from being able to stay inflated.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.It is unlikely that this type of damage was present at the time of manufacturing.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.

• Brand Name: ET TUBE,CF,4.0
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24054166
• Report Number: 3003898360-2026-00021
• Device Sequence Number: 9465759
• Product Code: BTR
• UDI-Device Identifier: 04026704396740
• UDI-Public: (01)04026704396740(11)240223(17)290221(10)73B2400784(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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
• Device Catalogue Number: 5-10108
• Device Lot Number: 73B2400784
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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
• Patient Sex: Unknown