MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,3.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10107
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the cuff didn't inflate during the inflation test before use.Therefore, a new kit was used instead.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of "unable to inflate - cuff" was confirmed based upon the sample received.The sample was found to have its inflation line flattened near the distal end of the pilot balloon which prevented the cuff from being able to inflate.A device history record review was performed with no evidence to suggest a manufacturing related cause.All et tubes are 100% inspected for inflation and deflation at manufacturing by inflating the cuffs and allowing them to remain inflated for four hours prior to being deflated.Therefore, it is unlikely that the damage to the inflation line was present at the time of manufacturing.It could not be determined how or when this defect occurred.Teleflex will continue to monitor and trend on this defect.
Event or Problem Description
It was reported that the cuff didn't inflate during the inflation test before use.Therefore, a new kit was used instead.

• Brand Name: ET TUBE,CF,3.5
• 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: 18542595
• Report Number: 3003898360-2024-00144
• Device Sequence Number: 15723450
• Product Code: BTR
• UDI-Device Identifier: 04026704396733
• UDI-Public: 04026704396733
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/27/2023

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 Expiration Date: 01/29/2024
• Device Catalogue Number: 5-10107
• Device Lot Number: 73A1900944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2019
• 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
• Patient Sex: Unknown