MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN/HVT ET TUBE, HVT, 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10314
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of "torn/ruptured - info not provided" could not be confirmed based upon the sample received.The customer returned one unit 5-10314 et tube, hvt, 7.0 for investigation.The returned et tube was able to inflate and deflate with no difficulty.All et tubes are 100% inspected for both inflation and deflation at the time of manufacturing.A device history record review was performed and showed no evidence to suggest a manufacturing related issue.No functional issues were found with the returned device.
Event or Problem Description
It was reported that: "et tubes burst balloons upon insertion in patient.".

• Brand Name: SHERIDAN/HVT ET TUBE, HVT, 7.0
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22724367
• Report Number: 3003898360-2025-00611
• Device Sequence Number: 9143575
• Product Code: BTR
• UDI-Device Identifier: 04026704397037
• UDI-Public: (01)04026704397037(11)240425(17)290424(10)73D2400940(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 07/10/2025

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: 5-10314
• Device Lot Number: 73D2400940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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
• Patient Sex: Unknown