MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, CUFFED, SPIRAL-FLEX 6.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-12613
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " the cuff didn't inflate during the test before use.Therefore, a new unit was used instead".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-12613 et tube, cuffed, spiral-flex 6.5 for investigation.The returned et tube was visually examined with and without magnification.Visual examination of the returned et tube revealed that the sample appears typical.No other defects or anomalies were observed.A functional inspection was performed to attempt to inflate and deflate the balloon cuff on the returned et tube.A lab inventory syringe filled with air was connected to the valve of the pilot balloon.Upon injection of air, the balloon cuff was unable to inflate.The cuff was fully deflated and was submerged under water.Upon injection of air, the balloon cuff leaked from the proximal end of the cuff where the cuff is glued to the tube.The manufacturing site was consulted for this issue, and it was confirmed that a portion of the adhesive material was incorrectly applied to the cuff which prevented the cuff from being properly sealed and unable to stay inflated.This is a manufacturing related issue.Non-conformance has been opened to further investigate this issue.Device history record investigation did not show issues related to complaint.The ifu for this product, was re viewed as a part of this complaint investigation.The ifu states, "the tracheal tube cuff inflation system, including the valve, should be checked prior to intuba-tion.If a malfunction is detected in any part of the inflation system, the tube should not be used", "the tracheal tube cuff should be slowly inflated with the minimum amount of air required to pro-vide an effective tracheal seal.Do not inflate with a measured volume of air or by "feel" of pressure in the syringe since little resistance should be felt during inflation", and "care should be tak-en to avoid damaging the thin-walled cuffs during intubation.If cuff is damaged, the tube should not be used".The reported complaint of "inflation issue - unable to inflate " was confirmed based upon the sample received.Upon functional inspection, the balloon cuff leaked from the proximal end of the cuff where the cuff is glued to the tube.It appears that the adhesive material was incorrectly placed for a portion of the cuff which resulted in a hole that prevented the cuff from being properly sealed and unable to stay inflated.This is a manufacturing related issue.Non-conformance has been opened to further investigate this issue.
Event or Problem Description
It was reported " the cuff didn't inflate during the test before use.Therefore, a new unit was used instead".No patient involvement reported.

• Brand Name: ET TUBE, CUFFED, SPIRAL-FLEX 6.5
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24054088
• Report Number: 3003898360-2026-00020
• Device Sequence Number: 9856747
• Product Code: BTR
• UDI-Device Identifier: 04026704397396
• UDI-Public: (01)04026704397396(11)241020(17)291019(10)73K2400580(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K844296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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
• Device Catalogue Number: 5-12613
• Device Lot Number: 73K2400580
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2024
• 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: N/A.; N/A.
• Patient Sex: Unknown