MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, SHER-I-BRONCH, LS, 35 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Catalog Number	5-16035
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - balloon cuff" could not be confirmed based upon the investigation of the sample received.The customer returned one unit 5-16035 et tube, sher-i-bronch, ls, 35 fr for investigation.The returned et tube was able to inflate and deflate with no difficulty.A review of the manufacturing process confirmed that all et tubes are 100% inspected for both inflation and deflation at the time of manufacturing.Any such defects would be detected as out of specification.A device history record review was performed and showed no evidence to suggest a manufacturing related issue.No functional issues were found with the returned device.
Event or Problem Description
It was reported that: "(b)(6) 2025, the doctor found cuff leakage when doing testing before using on patient.Change new tube.".
Event or Problem Description
It was reported that: "(b)(6) 2025, the doctor found cuff leakage when doing testing before using on patient.Change new tube.".
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate 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.

• Brand Name: ET TUBE, SHER-I-BRONCH, LS, 35 FR
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFF
• 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: 23971988
• Report Number: 3003898360-2026-00008
• Device Sequence Number: 21060128
• Product Code: CBI
• UDI-Device Identifier: 14026704941169
• UDI-Public: (01)14026704941169(11)231010(17)281009(10)73K2300219(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2025

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: 5-16035
• Device Lot Number: 73K2300219
• 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: 12/14/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• 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
• Patient Sex: Unknown