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 Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the tracheal cuff was found out that it could not be inflated during the test.".
Event or Problem Description
It was reported that "the tracheal cuff was found out that it could not be inflated during the test.".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of "unable to inflate - balloon cuff" was confirmed based upon the sample received.The customer returned one unit 5-16035 et tube, sher-i-bronch, ls, 35 fr for investigation.Upon 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 is caused by an assembly issue during manufacturing.A device history record review was performed, and no relevant findings were identified.Further investigation has been initiated under teleflex quality systems to evaluate this issue.

• 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: 22629085
• Report Number: 3003898360-2025-00599
• Device Sequence Number: 21067063
• Product Code: CBI
• UDI-Device Identifier: 04026704397600
• UDI-Public: (01)04026704397600(11)240612(17)270728(10)73F2400128(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 73F2400128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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