MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,5.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10111
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that: "the cuff didn't inflate during the test before use.Therefore, a new unit was used instead.There was no patient involved.".
Event or Problem Description
It was reported that: "the cuff didn't inflate during the test before use.Therefore, a new unit was used instead.There was no patient involved.".
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10111 et tube, cf,5.5 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the valve on the pilot balloon was slightly crushed, making it ovular in shape rather than circular.Functional inspection was performed to attempt to inflate and deflate the cuff on the returned et tube.However, the lab inventory syringe was unable to be connected to the pilot balloon valve due to the valve being damaged.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.Therefore, it is unlikely that the damage to the valve was present at the time of manufacturing.It could not be determined how or when this defect occurred.Teleflex will continue to monitor and trend on this defect.The device history review 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." the reported complaint of "unable to inflate - cuff" was confirmed based upon the sample received.The sample was found to have its valve on the pilot balloon was slightly crushed, making it ovular in shape rather than circular.Due to this damage, a syringe could not be connected to the valve to inflate and deflate the balloon cuff.A device history record review was performed with no evidence to suggest a manufacturing related cause.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.Therefore, it is unlikely that the damage to the valve was present at the time of manufacturing.It could not be determined how or when this defect occurred.Teleflex will continue to monitor and trend on this defect.

• Brand Name: ET TUBE,CF,5.5
• 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: 21855568
• Report Number: 3003898360-2025-00332
• Device Sequence Number: 14632552
• Product Code: BTR
• UDI-Device Identifier: 04026704396771
• UDI-Public: (01)04026704396771(11)240516(17)290515(10)73E2400513(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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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 Catalogue Number: 5-10111
• Device Lot Number: 73E2400513
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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: N/A.; N/A.
• Patient Sex: Unknown