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

Catalog Number	5-16035
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: " on (b)(6) 2025, the doctor found cuff leakage and cracks at the junction when doing testing before using on patient.Change new tube.".
Additional Manufacturer Narrative
Qn# (b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.The issue reported "leak - balloon cuff" was not observed in the current manufacturing process.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determine the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Part number reported is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 13 samples were taken from the current production; the samples were functionally inspected, and issue reported "leak - balloon cuff" was not observed in the current manufacturing process.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: " (b)(6) 2025, the doctor found cuff leakage and cracks at the junction when doing testing before using on patient.Change new tube.".

• Brand Name: SHERIDAN 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: 22629603
• Report Number: 3003898360-2025-00600
• Device Sequence Number: 20831646
• Product Code: CBI
• UDI-Device Identifier: 04026704397600
• UDI-Public: (01)04026704397600(11)230927(17)280926(10)73J2300684(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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 73J2300684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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