MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN/CF ET TUBE,CF,8.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10114
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Failure mode "leak - device leak - cuff" could be confirmed with picture and videos attached.However, it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause & corrective actions.Dhr investigation did not show issues related to complaint.If the complaint samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported that: "(b)(6) 2025, when tube was inserted, there was a quality problem with the suction balloon.After the gas was injected, the balloon was filled but then the balloon collapsed.".
Additional Manufacturer Narrative
(b)(4).Additional information: the material number, lot number & udi number were updated to 5-10114, 73j2300690 and (b)(4) respectively.Device evaluation: the reported complaint of "leak - device leak - cuff" could not be confirmed based upon the investigation of the sample received.The customer provided one photo and two videos and returned one unit 5-10114 et tube, cf, 7.0 for investigation.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 no relevant findings were identified.No functional issues were found with the returned device.
Event or Problem Description
It was reported that: "on (b)(6) 2025, when tube was inserted, there was a quality problem with the suction balloon.After the gas was injected, the balloon was filled but then the balloon collapsed.".

• Brand Name: SHERIDAN/CF ET TUBE,CF,8.0
• 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: 22141769
• Report Number: 3003898360-2025-00449
• Device Sequence Number: 15218870
• Product Code: BTR
• UDI-Device Identifier: 04026704396801
• UDI-Public: (01)04026704396801(11)230919(17)280918(10)73J2300690(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K822082
• 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): 05/08/2025

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: 5-10114
• Device Lot Number: 73J2300690
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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