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

Catalog Number	5-10116
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "cuff would not stay inflated after intubation.Each cuff was inflated prior to intubation to test.Associated complaints 3003898360-2025-00571, 3003898360-2025-00598.
Additional Manufacturer Narrative
(b)(4).The customer returned two units 5-10116 et tube,cf,8.0 for investigation.One sample was the actual sample that caused this complaint issue and one sample was a representative sample.The et tubes were visually examined with and without magnification.Visual examination of the returned devices revealed that both samples appeared typical.No defects or anomalies were observed.Functional inspection was performed on the returned devices to test for proper inflation and deflation.First, a lab inventory syringe was filled with air and attached to the pilot balloon of the actual sample.Upon injection of air, the balloon cuff was unable to stay inflated.The device was submerged underwater in order to test for leaks.Upon inflation, the device leaked from multiple holes in the balloon cuff.Dhr investigation did not show issues related to complaint.Next, the representative sample was tested.Upon injection of air, the balloon cuff was able to properly inflate.The syringe was reattached to the pilot balloon and the balloon cuff was able to properly deflate.The device was submerged underwater in order to test for leaks.Upon inflation, no leaks were detected.No functional issues were found with the representative sample.The reported complaint of "leak - device leak - cuff" was confirmed based upon the samples received.Two samples were returned: one actual sample that caused this complaint issue and one representative sample.The returned actual sample was found to have multiple holes in the balloon cuff which prevented it from being able to stay inflated.No issues were found with the representative sample.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.It is unlikely that this type of damage was present at the time of manufacturing.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22574186
• Report Number: 3003898360-2025-00597
• Device Sequence Number: 9566424
• Product Code: BTR
• UDI-Device Identifier: 04026704396825
• UDI-Public: (01)04026704396825(11)231012(17)281010(10)73K2300382(21)
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 5-10116
• Device Lot Number: 73K2300382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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
• Patient Sex: Unknown