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

Catalog Number	5-10108
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the cuff didn't inflate during the test before use.The user opened another unit of the same lot#, but the same issue occurred.Therefore, the third unit (lot#: unknown) was used".No patient involvement.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10108 et tube,cf,4.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the sample 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.The ifu for this product was reviewed as a part of this complaint investigation.A device history record review was performed, and no relevant findings were identified.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 the 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" pressure in the syringe since little resistance should be felt during inflation." a corrective action is not required at this time as it appears that unintentional user error caused or contributed to this event.All et tubes are 100% inspected for inflation and deflation at manufacturing by inflating the cuffs and allowing them to remain inflated for four hours prior to being deflated.The reported complaint of "unable to inflate - cuff" was confirmed based upon the sample received.The returned et tube 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.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the cuff didn't inflate during the test before use.The user opened another unit of the same lot#, but the same issue occurred.Therefore, the third unit (lot#: unknown) was used".No patient involvement.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21805685
• Report Number: 3003898360-2025-00311
• Device Sequence Number: 7408589
• Product Code: BTR
• UDI-Device Identifier: 04026704396740
• UDI-Public: (01)04026704396740(11)230727(17)280726(10)73G2301136(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Catalogue Number: 5-10108
• Device Lot Number: 73G2301136
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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
• Patient Sex: Unknown