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

Catalog Number	5-10116
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "ett tube did not inflate during procedure".No patient harm or injury.No medical intervention required.A new endotracheal tube was placed.The patient's condition was reportedly "stable before and after equipment malfunction".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "ett tube did not inflate during procedure".No patient harm or injury.No medical intervention required.A new endotracheal tube was placed.The patient's condition was reportedly "stable before and after equipment malfunction".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned two units 5-10116 et tube,cf,8.0 for investigation.Two representative samples were returned.An actual sample was not returned.The representative samples were visually examined with and without magnification.Visual examination of the returned devices revealed that the samples appear typical.No defects or anomalies were observed.A functional inspection was performed to attempt to inflate and deflate the balloon cuff on the returned et tubes.A lab inventory syringe filled with air was connected to the valve of the pilot balloon of one of the returned samples.Upon injection of air, both the pilot and cuff immediately inflated.The syringe was then removed and the cuff and pilot balloon were inspected for leaks.No leaks were detected.The syringe was then reattached in order to deflate the balloons.Both the pilot balloon and balloon cuff were able to deflate.The sample was submerged underwater to test for any leaks.However, no leaks were detected.This process was repeated for the other sample with the same results.No issues were found with the returned samples as they were both able to properly inflate and deflate.A device history record review was performed and no relevant findings were identified.The states, "the tracheal tube cuff inflation system, including the valve, should be checked prior to intubation.If a malfunction is a detected in any part of the system, the tube should not be used." "care should be taken to avoid damaging the thin-walled cuffs during intubation.If cuff is damaged, the tube should not be used." the ifu also states, "cuff pressure should be monitored routinely to assure that an adequate tracheal seal is maintained and that the cuff has not become over-inflated.The tracheal tube cuff should be slowly inflated with the minimum amount of air required to provide 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." the reported complaint could not be confirmed since the actual sample was not returned.The customer returned two representative samples in place of the actual sample that resulted in the complaint issue.Upon functional inspection, no problems were found with the returned devices as they were both able to properly inflate and deflate.No leaks were found with the samples.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.The probable cause of this complaint issue could not be determined without the actual device.

• Brand Name: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19260390
• Report Number: 3003898360-2024-00431
• Device Sequence Number: 17812491
• Product Code: BTR
• UDI-Device Identifier: 04026704396825
• UDI-Public: 04026704396825
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: 5-10116
• Device Lot Number: 73G2300459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown