MAUDE Adverse Event Report: TELEFLEX MEDICAL 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	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Correction to section d.4: udi was updated from (b)(4) to (b)(4) to include the full udi.The customer returned one unit 5-12514 et tube, cuffed oral, spiral-flex 7.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appeared typical.The bite block was returned on the et tube.Functional inspection was performed on the returned device to test for proper inflation and deflation.A lab inventory syringe was filled with air and attached to the pilot balloon.Upon injection of air, the balloon cuff was unable to stay inflated.The sample was submerged underwater to test for leaks.Upon inflation, the et tube leaked from a hole underneath the proximal end of the bite block.The bite block was removed and a small hole was found on the inflation line.Per dhr the et tube, cuffed oral, spiral-flex 7.0 lot # 73k2300117 was manufactured on 10/17/2023 a total of (b)(4).Lot was released on (b)(6) 2023.Dhr investigation did not show issues related to complaint.The ifu for this product, was reviewed as a part of this complaint investigation.The ifu 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 of "leak - device leak - cuff" was confirmed based upon the sample received.The returned et tube was found to have a small hole in the inflation line which prevented the balloon cuff from staying inflated.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.It could not be determined when or how the et tube got damaged, but it is unlikely that this type of damage was present at the time of manufacturing.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: "20 may 2024, the doctor found cuff leakage when using on patient.".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2024, the doctor found cuff leakage when using on patient.".

• Brand Name: 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19526994
• Report Number: 3003898360-2024-00674
• Device Sequence Number: 7606591
• Product Code: BTR
• UDI-Device Identifier: 04026704397310
• UDI-Public: 04026704397310
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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
• 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: 06/10/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown