MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, HVT, 8.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10317
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
I was reported that "endotracheal tube checked with balloon inflating with air prior to insertion.After ett insertion unable to ventilate due to cuff leak.Presumed esophageal insertion.Ett removed and reinserted but still unable to ventilate due to leak.Ett removed and changed to [other manufacturer]".No further information has been made available by the customer.
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.

• Brand Name: ET TUBE, HVT, 8.5
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 23595984
• Report Number: 3003898360-2025-00861
• Device Sequence Number: 13340717
• Product Code: BTR
• UDI-Device Identifier: 04026704397068
• UDI-Public: (01)04026704397068(11)230822(17)280821(10)73H2300857(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: 5-10317
• Device Lot Number: 73H2300857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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