MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN/CF ET TUBE,CF,8.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10117
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the inflation cuffs are not holding air properly.There was no reported patient harm or consequence.".
Event or Problem Description
It was reported that: "the inflation cuffs are not holding air properly.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of "unable to inflate - cuff" could not be confirmed since the actual sample was not returned.The customer returned one representative sample in place of the actual sample that resulted in the complaint issue.Upon functional inspection, no problems were found with the returned device as it was able to properly inflate and deflate.No leaks were found with the sample.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.The probable cause of this complaint issue could not be determined without the actual device.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: SHERIDAN/CF ET TUBE,CF,8.5
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• 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: 23298463
• Report Number: 3003898360-2025-00757
• Device Sequence Number: 14674952
• Product Code: BTR
• UDI-Device Identifier: 04026704396832
• UDI-Public: (01)04026704396832(11)240411(17)290410(10)73D2400514(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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: 5-10117
• Device Lot Number: 73D2400514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown