MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,HVT,8.0,NOVA PLUS; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	V5-10316
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "i inflated the balloon and did a quick squeeze prior to intubation, and it seemed to hold air.However, i quickly deflated the balloon so perhaps i didn't leave the balloon inflated long enough to ensure it would stay inflated once placed.Another possibility is that the balloon was working but it got punctured by a tooth on insertion, although it was a pretty smooth insertion so i'm not sure that was the case.The connector was firmly attached and there was no detachment as it was an issue with the ett cuff not holding air.The patient had poor reserve from respiratory failure due to decompensated heart failure and was requiring 15l nrb with spo2 only 88-89% prior to intubation.His spo2 maintained 93-95 during bvm via ett and his tube was exchanged without issue prior to hooking him up to the vent as the deflated cuff was noticed immediately after the ett was inserted.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint of "does not stay inflated - cuff" was confirmed based upon the investigation of the sample received.The customer returned one-unit v5-10316 et tube, hvt,8.0, nova plus for investigation.The returned et tube was found to have a hole in the balloon cuff which prevented it from being able to stay inflated.A device history record review was performed with no evidence to suggest a manufacturing related cause.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.Additionally, the ifu for this product states, "the tracheal tube cuff inflation system, including the valve, should be checked prior to intubation.If a malfunction is a detected in any part of the system, the tube should not be used." "care should be taken to avoid damaging the thin-walled cuffs during intubation.If cuff is damaged, the tube should not be used." the ifu also states, "the tracheal tube cuff should be slowly inflated with the minimum amount of air required to provide an effective tracheal seal.Do not inflate with a measured volume of air or by "feel" of pressure in the syringe since little resistance should be felt during inflation.Cuff volume and pressure should be monitored routinely to assure that an adequate tracheal seal is maintained and that the cuff has not become over inflated.".It is unlikely that this type of damage was present at the time of manufacturing.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that: "i inflated the balloon and did a quick squeeze prior to intubation, and it seemed to hold air.However, i quickly deflated the balloon so perhaps i didn't leave the balloon inflated long enough to ensure it would stay inflated once placed.Another possibility is that the balloon was working but it got punctured by a tooth on insertion, although it was a pretty smooth insertion so i'm not sure that was the case.The connector was firmly attached and there was no detachment as it was an issue with the ett cuff not holding air.The patient had poor reserve from respiratory failure due to decompensated heart failure and was requiring 15l nrb with spo2 only 88-89% prior to intubation.His spo2 maintained 93-95 during bvm via ett and his tube was exchanged without issue prior to hooking him up to the vent as the deflated cuff was noticed immediately after the ett was inserted.There was no reported patient harm or consequence.".

• Brand Name: ET TUBE,HVT,8.0,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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23803395
• Report Number: 3003898360-2025-00909
• Device Sequence Number: 9333919
• Product Code: BTR
• UDI-Device Identifier: 04026704588794
• UDI-Public: (01)04026704588794(11)250225(17)300224(10)73B2500712(21)
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: V5-10316
• Device Lot Number: 73B2500712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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