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

Catalog Number	5-10314
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that "ett has a leak in the cuff.Clinician verified the leak by instilling saline into the cuff to see the leak.This was discovered after inflating the cuff after intubation to verify return of tidal volumes.The cuff was checked prior to placing the ett tube and only discovered to be leaking after vent alarms were going off indicating insufficient volume to the patient.Patient was re-intubated 3 times until cuff pressure could be maintained and volumes from vent could be delivered".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - cuff" was confirmed based upon the investigation of the sample received.The customer returned one unit 5-10314 et tube, hvt, 7.0 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.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.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 detected in any part of the system, the tube should not be used" and "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, "cuff pressure should be monitored routinely to assure that an adequate tracheal seal is maintained and that the cuff has not become over-inflated.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.".A device history record review was performed, and no relevant findings were identified.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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "ett has a leak in the cuff.Clinician verified the leak by instilling saline into the cuff to see the leak.This was discovered after inflating the cuff after intubation to verify return of tidal volumes.The cuff was checked prior to placing the ett tube and only discovered to be leaking after vent alarms were going off indicating insufficient volume to the patient.Patient was re-intubated 3 times until cuff pressure could be maintained and volumes from vent could be delivered".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 24400646
• Report Number: 3003898360-2026-00074
• Device Sequence Number: 10113304
• Product Code: BTR
• UDI-Device Identifier: 14026704941091
• UDI-Public: (01)14026704941091(11)250308(17)300307(10)73C2500204(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 01/23/2026

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: 5-10314
• Device Lot Number: 73C2500204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2025
• 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
• Patient Sex: Unknown