MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN ET TUBE, SHER-I-BRONCH, LS, 37 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Catalog Number	5-16037
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(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.
Event or Problem Description
It was reported that: "after intubation, there was no leak with one-lung ventilation.However, air leaking occurred when transitted to two-lung ventilation after 2 hours surgery.Patient's saturation dropped, so doctor changed a tube immediately." the patient was reported as fine post the procedure.
Event or Problem Description
It was reported that: "after intubation, there was no leak with one-lung ventilation.However, air leaking occurred when transmitted to two-lung ventilation after 2 hours surgery.Patient's saturation dropped, so doctor changed a tube immediately." the patient was reported as fine post the procedure.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of "leak - tube" could not be confirmed based upon the sample received.The customer returned one unit 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation.Visual examination of the returned sample revealed no defects or anomalies.The returned et tube was able to inflate and deflate with no difficulty.All et tubes are 100% inspected for both inflation and deflation at the time of manufacturing.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.

• Brand Name: SHERIDAN ET TUBE, SHER-I-BRONCH, LS, 37 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: 22000629
• Report Number: 3003898360-2025-00387
• Device Sequence Number: 9125683
• Product Code: CBI
• UDI-Device Identifier: 04026704397617
• UDI-Public: (01)04026704397617(11)231010(17)281009(10)73K2300118(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: 5-16037
• Device Lot Number: 73K2300118
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown