MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,6.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN044729
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states that the "patient brought into the operating theatre.The anesthetist intubated the patient and inflated the cuff.When the ventilator was connected, there was a leak and no air volume.The anesthetist decided to ventilate the patient manually using the bavu.Once again, the sound of a leak was heard.Guide wire was positioned to change catheter.It was observed that the cuff was torn.The device was replaced with success using a device from another brand.There was no clinical consequences for the patient because the change of device reference for the intubation tube was well performed by clinical team." the patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(6).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The report states that the "patient brought into the operating theatre.The anesthetist intubated the patient and inflated the cuff.When the ventilator was connected, there was a leak and no air volume.The anesthetist decided to ventilate the patient manually using the bavu.Once again, the sound of a leak was heard.Guide wire was positioned to change catheter.It was observed that the cuff was torn.The device was replaced with success using a device from another brand.There was no clinical consequences for the patient because the change of device reference for the intubation tube was well performed by clinical team." the patient status is reported as "fine".

• Brand Name: ET TUBE,CF,6.5
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17542005
• Report Number: 3003898360-2023-01224
• Device Sequence Number: 7570396
• Product Code: BTR
• UDI-Device Identifier: 14026704759122
• UDI-Public: 14026704759122
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 07/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2023
• Device Model Number: IPN044729
• Device Catalogue Number: 5-10113
• Device Lot Number: 73G1800793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• 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: N/A.; N/A.
• Patient Sex: Unknown