MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CUFFED ORAL,SPIRAL-FLEX 8.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-12516
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Failure mode "leak - device leak - cuff" could not be confirmed with picture attached.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) 2026, the doctor found cuff leakage when using on patient.Change new tube.The patient was reported as fine.".

• Brand Name: ET TUBE,CUFFED ORAL,SPIRAL-FLEX 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24455233
• Report Number: 3003898360-2026-00090
• Device Sequence Number: 13253967
• Product Code: BTR
• UDI-Device Identifier: 04026704397334
• UDI-Public: (01)04026704397334(11)240730(17)290729(10)73G2400826(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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 5-12516
• Device Lot Number: 73G2400826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2024
• 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
• Patient Sex: Unknown