MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN926926
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor found cuff leakage when using on patient.Then changed new one, no impact on patient".Patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Per dhr the et tube,cf,7.5 lot # 73j2100701 was manufactured on (b)(6) 2021 a total of 16,800 pieces.Lot was released on (b)(6) 2021.Dhr investigation did not show issues related to complaint.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ET TUBE,CF,7.5
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16942388
• Report Number: 3003898360-2023-00727
• Device Sequence Number: 19736318
• Product Code: BTR
• UDI-Device Identifier: 14026704759146
• UDI-Public: 14026704759146
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2026
• Device Model Number: IPN926926
• Device Catalogue Number: 5-10115
• Device Lot Number: 73J2100701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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