MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FLEXI-SET CUFFED 7.0MM; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN044685
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported event: endotracheal tube cuff leaked and required tube to be replaced.No reported injury.Medwatch report#: (b)(4).
Event or Problem Description
Reported event: endotracheal tube cuff leaked and required tube to be replaced.No reported injury.(medwatch report#: (b)(4)).
Additional Manufacturer Narrative
(b)(4).As no sample was returned for investigation, therefore 1 production representative sample was used for simulation.Visual inspection was performed on the production representative sample.There is no obvious defect observed during the inspection.The cuff pressure of the production representative sample was then inflated to 25mbar by using calibrated endotest.The cuff pressure was observed to be maintained at 25mbar for 30 minutes.The production representative sample was then immersed into the water and undergo water leak test.No bubbles were observed flowing out from the pilot balloon and cuff during the water leak test.Color water test was then conducted by injecting color water into the cuff to further identify any point of leakage.There is no cuff leakage and pilot balloon leakage found on the representative sample.Based on the investigation conducted, the complaint on this complaint mode could not be confirmed.There is no physical evidence of failure since there is no sample available for investigation.

• Brand Name: FLEXI-SET CUFFED 7.0MM
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16265435
• Report Number: 8040412-2023-00005
• Device Sequence Number: 14524401
• Product Code: BTR
• UDI-Device Identifier: 04026704547616
• UDI-Public: 04026704547616
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K961837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: IPN044685
• Device Catalogue Number: 504570
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/24/2023
• 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: A
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic