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

Catalog Number	V5-10315
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
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 determine 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: "pt was intubated with 7.5 ett, hole present in the balloon (unable to keep inflated s/p intubation).Tube immediately removed and replaced with new ett.No harm to pt.Unable to see leak in balloon until balloon filled with saline and leak was vizualized".

• Brand Name: ET TUBE,HVT,7.5,NOVA PLUS
• 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: 24727893
• Report Number: 3003898360-2026-00162
• Device Sequence Number: 13078963
• Product Code: BTR
• UDI-Device Identifier: 04026704588787
• UDI-Public: (01)04026704588787(11)240729(17)290728(10)73G2400813(21)
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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: V5-10315
• Device Lot Number: 73G2400813
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2024
• 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