MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10115
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.Dhr investigation did not show issues related to complaint.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported that: "on (b)(6), the patient underwent a nasal tracheal intubation.On (b)(6), it was discovered that the tracheal tube was leaking air.Immediately, the same batch number of tracheal tube was replaced.However, the airbag could not be inflated.The patient's blood oxygen level was low and they were experiencing shortness of breath.After replacing with a subglottic tracheal tube, there was no leakage anymore.The patient no longer had shortness of breath and their blood oxygen level returned to normal." associated complaint 3003898360-2025-00779 and 3003898360-2025-00780.

• Brand Name: ET TUBE,CF,7.5
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23365432
• Report Number: 3003898360-2025-00780
• Device Sequence Number: 21111860
• Product Code: BTR
• UDI-Device Identifier: 04026704396818
• UDI-Public: (01)04026704396818(11)230816(17)280815(10)73H2300641(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/28/2025

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: 5-10115
• Device Lot Number: 73H2300641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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: NOT REPORTED.
• Patient Sex: Unknown