MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,LTS,6.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-11112
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
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.
Event or Problem Description
It was reported that "end user pre-tested inflation cuff, no issues.Intubated patient, and once inside, patient moved, tube heard a pop.Removed tube and found cuff deflated.Reintubated patient with new tube, no issues, continued procedure".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - device leak - cuff" was confirmed based upon the investigation of the sample received.The customer returned one unit 5-11112 et tube, lts, 6.0 for investigation.The returned sample was found to have a large hole in the balloon cuff which would have prevented it from being able to stay inflated.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.It is unlikely that this type of damage was present at the time of manufacturing.Additionally, the ifu 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." "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 on potential lot based on sales history, and no relevant findings were identified.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that "end user pre-tested inflation cuff no issues.Intubated patient and once inside patient moved tube heard a pop.Removed tube and found cuff deflated.Reintubated patient with new tube, no issues, continued procedure".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: ET TUBE,LTS,6.0
• 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: 23596044
• Report Number: 3003898360-2025-00866
• Device Sequence Number: 13090533
• Product Code: BTR
• UDI-Device Identifier: 04026704397235
• UDI-Public: (01)04026704397235(11)250320(17)300319(10)73C2500757(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/30/2025

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: 5-11112
• Device Lot Number: 73C2500757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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