MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,4.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10108
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the cuff didn't inflate during the inflation test before use.Therefore, a new kit was used instead." this occured prior to use during functional testing.No patient harm or injury.
Event or Problem Description
It was reported "the cuff didn't inflate during the inflation test before use.Therefore, a new kit was used instead." this occured prior to use during functional testing.No patient harm or injury.
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of "unable to inflate - cuff" was confirmed based upon the sample received.The returned et tube was found to have its inflation line severed where it enters the tube.A device history record review was performed, and no relevant findings were identified.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.Teleflex will continue to monitor and trend on this issue.

• Brand Name: ET TUBE,CF,4.0
• 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: 19014204
• Report Number: 3003898360-2024-00302
• Device Sequence Number: 8156444
• Product Code: BTR
• UDI-Device Identifier: 04026704396740
• UDI-Public: 04026704396740
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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: 5-10108
• Device Lot Number: 73C2300030
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown