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

Catalog Number	5-10316
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "cuff is blowing out." additional information received on 15apr2025: it is my understanding from my front-line staff that we have experienced at least three of these endotracheal tubes failing while in use on a patient in our icu.The failures that have taken place have occurred on three separate patients.The last incident i personally inspected the ett which had a leak in the middle of the cuff wall.This patient had been intubated for approximately 48 hours with this tube before it failed.Associated complaints 3003898360-2025-00407, 3003898360-2025-00408, 3003898360-2025-00409.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of "leak - info not provided" could not be confirmed upon investigation of the returned sample.The customer returned two representative samples in place of the actual sample that resulted in the complaint issue.Upon functional inspection, no problems were found with the returned devices as they were both able to properly inflate and deflate.No leaks were found with the samples.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.The probable cause of this complaint issue could not be determined without the actual device.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "cuff is blowing out.".Additional information received on 15apr2025: it is my understanding from my front-line staff that we have experienced at least three of these endotracheal tubes failing while in use on a patient in our icu.The failures that have taken place have occurred on three separate patients.The last incident i personally inspected the ett which had a leak in the middle of the cuff wall.This patient had been intubated for approximately 48 hours with this tube before it failed.Associated complaints 3003898360-2025-00407, 3003898360-2025-00408, 3003898360-2025-00409 and 3003898360-2025-00365.

• Brand Name: SHERIDAN/HVT CUFFED ET TUBE
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21933650
• Report Number: 3003898360-2025-00365
• Device Sequence Number: 9096345
• Product Code: BTR
• UDI-Device Identifier: 04026704397051
• UDI-Public: (01)04026704397051(11)240628(17)290627(10)73F2401020(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 04/14/2025

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: 5-10316
• Device Lot Number: 73F2401020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown