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

Catalog Number	5-16037
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "prior to use during testing, found cuff could not inflate".
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.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Dhr investigation did not show issues related to complaint.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - balloon cuff" was confirmed based upon the investigation of the sample received.The customer returned one unit 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation.During functional inspection, the tracheal (white) inflation line was found to be obstructed at the distal end of the pilot balloon which prevented the balloon cuff from inflating properly.The obstruction was caused by adhesive material getting into the distal end of the pilot balloon during assembly and blocking the inflation line.A device history record review was performed, and no relevant findings were identified.This issue was the subject of a prior investigation, and corrective actions were previously implemented by teleflex quality systems to address this issue.The returned sample was manufactured prior to these corrective actions.
Event or Problem Description
It was reported that: "prior to use during testing, found cuff could not inflate".

• Brand Name: 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: 23776387
• Report Number: 3003898360-2025-00907
• Device Sequence Number: 18684593
• Product Code: CBI
• UDI-Device Identifier: 14026704941176
• UDI-Public: (01)14026704941176(11)231212(17)270428(10)73M2300315(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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 73M2300315
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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: N/A.; N/A.
• Patient Sex: Unknown