MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. TRACHEAL TUBE, CUFFED; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	IPN041544
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states "after we inflate the cuff as much as we can safely, we can still hear air escaping around the tube which suggests there is not an appropriate seal of the trachea.Our concern with these ett is that they are not being correctly inflated to have a safe pressure on the cat's tracheal wall and that they are not creating a tight seal which is allowing isoflurane to escape around the tube".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The report states "after we inflate the cuff as much as we can safely, we can still hear air escaping around the tube which suggests there is not an appropriate seal of the trachea.Our concern with these ett is that they are not being correctly inflated to have a safe pressure on the cat's tracheal wall and that they are not creating a tight seal which is allowing isoflurane to escape around the tube".
Additional Manufacturer Narrative
(b)(4).Additional information received on 02 june 2023 states that "there have been no signs of defect to the cuff on extubation, we always check our cuffs prior to placement and all patients have recovered from their ga without problems".Complaint verification testing could not be performed as it was reported that the sample is not available for return.The manufacturing site reports "teleflex endotracheal tube is designed and intended for human use only.Labelling and ifu are created based on human use and market feedback.It is not design for other purpose and the drug used may not be compatible to the device.".

• Brand Name: TRACHEAL TUBE, CUFFED
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17011747
• Report Number: 8040412-2023-00234
• Device Sequence Number: 12520542
• Product Code: BTR
• UDI-Device Identifier: 14026704341495
• UDI-Public: 14026704341495
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/03/2023

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: IPN041544
• Device Catalogue Number: 112480-000025
• Device Lot Number: UNKNOWN
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/26/2023
• 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