MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN ET TUBE,CUFFED ORAL,SPIRAL-FLEX 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-12514
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "(b)(6) 2025, it was discovered that the balloon tube was leaking at the side of the connection to the cannula when doing testing before using on patient.Change new tube.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of "leak - device leak - tube" was confirmed based upon the sample received.The customer returned one unit 5-12514 et tube, cuffed oral, spiral-flex 7.0 for investigation.The returned et tube was found to have a hole in its inflation line near the "20" cm mark on the tube, underneath the bite block.The hole prevented the balloon cuff from being able to stay inflated.It is unlikely that this type of damage was present at the time of manufacturing.All et tubes are 100% inspected for inflation and deflation at manufacturing by inflating the cuffs and allowing them to remain inflated for four hours prior to being deflated.Therefore, it is unlikely that the root cause is manufacturing related.There was no damage to the bite block, so it is unknown how the inflation line got a hole in it beneath the bite block.A device history record review was performed, and no relevant findings were identified.The root cause could not be established for this complaint issue.This appears to be an isolated incident.Teleflex will continue to monitor and trend on this issue.
Event or Problem Description
It was reported that: "on (b)(6) 2025, it was discovered that the balloon tube was leaking at the side of the connection to the cannula when doing testing before using on patient.Change new tube.".

• Brand Name: SHERIDAN ET TUBE,CUFFED ORAL,SPIRAL-FLEX 7.0
• 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: 22607374
• Report Number: 3003898360-2025-00574
• Device Sequence Number: 20198064
• Product Code: BTR
• UDI-Device Identifier: 04026704397310
• UDI-Public: (01)04026704397310(11)231008(17)281007(10)73K2300117(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K844296
• 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): 07/02/2025

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: 5-12514
• Device Lot Number: 73K2300117
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2023
• 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