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

Model Number	IPN046759
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It is reported that "balloon does not hold air".At the time of this report it is unknown if this defect occurred while in use on a patient, however, additional clarifying questions have been asked to the customer.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Additional information received on 25 april 2023 states that this issue did not occur while in use on a patient.This information indicates that this was not a reportable event, thus, the initial mdr submitted on 5 april 2023 should be retracted.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It is reported that "balloon does not hold air".At the time of this report it is unknown if this defect occurred while in use on a patient, however, additional clarifying questions have been asked to the customer.If further information is received, the complaint file will be updated.

• Brand Name: ET TUBE,HVT,7.5,NOVA PLUS
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16685744
• Report Number: 3003898360-2023-00568
• Device Sequence Number: 15482844
• Product Code: BTR
• UDI-Device Identifier: 04026704588787
• UDI-Public: 04026704588787
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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 Model Number: IPN046759
• Device Catalogue Number: V5-10315
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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