MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10114
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "30 dec 2024, the doctor found cuff leakage during oral implantation.There was no rpeorted patient harm or consequence.".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 5-10315 et tube,cf,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 used as there was biological material present on the device.No defects or anomalies were observed.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 device was submerged underwater in order to test for leaks.Upon inflation, the device leaked from multiple holes in the balloon cuff.Per dhr the et tube, cf,7.0 lot # 73g2300753 was manufactured on 07/19/2023 a total of (b)(4) pieces.Lot was released on 07/31/2023.Dhr investigation did not show issues related to complaint.The reported complaint of "leak - device leak - cuff" was confirmed based upon the sample received.The returned et tube was found to have multiple holes in the balloon cuff which prevented it from being able to stay inflated.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.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "on (b)(6) 2024, the doctor found cuff leakage during oral implantation.There was no reported patient harm or consequence.".

• Brand Name: ET TUBE,CF,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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21158423
• Report Number: 3003898360-2025-00002
• Device Sequence Number: 20740923
• Product Code: BTR
• UDI-Device Identifier: 04026704396801
• UDI-Public: (01)04026704396801(11)230719(17)280718(10)73G2300753(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K822082
• 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): 12/30/2024

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: 5-10114
• Device Lot Number: 73G2300753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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