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" on (b)(6) 2024, the doctor found cuff leakage during oral implantation.".
Event or Problem Description
It was reported that "on (b)(6) 2024, the doctor found cuff leakage during oral implantation.".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 5-10114 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 was returned with a large hole in the balloon cuff which would prevent the cuff from staying inflated.The reported complaint of "leak - device leak - cuff" was confirmed based upon the sample received.The returned et tube was found to have a hole in the balloon cuff which would prevent 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 on complaints of this nature.

• 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: 21158246
• Report Number: 3003898360-2025-00001
• Device Sequence Number: 15367715
• Product Code: BTR
• UDI-Device Identifier: 04026704396801
• UDI-Public: (01)04026704396801(11)230503(17)280502(10)73E2300157(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: 73E2300157
• 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: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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