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

Catalog Number	5-10114
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "(b)(6) 2025, the doctor found cuff leakage when using on patient.Change the second tube, he doctor found cuff leakage again.Change the third tube.No harm or health consequences to the patient.Both the first ett and the second ett were pre-tested before the operation, but the inflation operation of the balloon after placement into the patient revealed that it could not be inflated, and re- catheterization was performed.Not any visible damage (i.E., torn, hole, etc)" associated complaints 3003898360-2025-00641.
Event or Problem Description
It was reported that "(b)(6) 2025, the doctor found cuff leakage when using on patient.Change the second tube, he doctor found cuff leakage again.Change the third tube.No harm or health consequences to the patient.Both the first ett and the second ett were pre-tested before the operation, but the inflation operation of the balloon after placement into the patient revealed that it could not be inflated, and re- catheterization was performed.No any visible damage (i.E., torn, hole, etc)" associated complaints (b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - device leak - cuff" was confirmed based upon the sample received.The customer returned one unit 5-10114 et tube, cf, 7.0 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.A review of the manufacturing process confirmed that all et tubes undergo 100% inspection for inflation and deflation, as part of the product release criteria.Any such defects would be detected as out of specification.The nature of the damage suggests it was not caused by a manufacturing process failure.A device history record review was performed, and no relevant findings were identified.Based upon the damage observed, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: SHERIDAN/CF ET TUBE,CF,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, NC 27560
• MDR Report Key: 22870591
• Report Number: 3003898360-2025-00640
• Device Sequence Number: 15677130
• Product Code: BTR
• UDI-Device Identifier: 04026704396801
• UDI-Public: (01)04026704396801(11)231020(17)281018(10)73K2300651(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 5-10114
• Device Lot Number: 73K2300651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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