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

Model Number	IPN044722
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: this was an incidence in cardiosurgery, intubation of small very young patient.Normal condition.Nurse inflated the cuff, visual inspection, lubricated the tube.But anesthiologist saw the patient didn't reach normal ventilation values.Higher pressures and saw patient was not ventilated enough.They heard air was leaking.So they extubated the patient and tried again with an other tube successfully.After another visual inspection of the first tube showed there was a hole in the tube close to the cuff.Patient was reported as fine post the procedure.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of "leak - gas leak - connector and/or tube" was confirmed based upon the sample received.Visual examination of the returned et tube revealed that there was a hole in the notch of the tube where the inflation line enters the tube.An investigation within the company was previously opened to further investigate this complaint issue by the manufacturing site.The hole in the notch was caused by an incorrect insertion of the pin that creates the notch during manufacturing.Corrective actions were implemented on 18 april 2023 to help prevent this issue from recurring.The returned sample was manufactured prior to these corrective actions.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: this was an incidence in cardiosurgery, intubation of small very young patient.Normal condition.Nurse inflated the cuff, visual inspection, lubricated the tube.But anesthiologist saw the patient didn't reach normal ventilation values.Higher pressures and saw patient was not ventilated enough.They heard air was leaking.So they extubated the patient and tried again with an other tube successfully.After another visual inspection of the first tube showed there was a hole in the tube close to the cuff.Patient was reported as fine post the procedure.

• 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: 18451984
• Report Number: 3003898360-2024-00061
• Device Sequence Number: 7780832
• Product Code: BTR
• UDI-Device Identifier: 04026704396733
• UDI-Public: 04026704396733
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 04/30/2024
• Device Model Number: IPN044722
• Device Catalogue Number: 5-10107
• Device Lot Number: 73E1900007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 4 KG