MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. CURVED REINFORCD CUFF ET; Tube, tracheal (w/wo connector)

Model Number	IPN040964
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
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
It was reported that the doctor found cuff leakage before using on patient when in a clinical setting before using on patient.It was changed to a new one.No impact on patient.
Event or Problem Description
It was reported that the doctor found cuff leakage before using on patient when in a clinical setting before using on patient.It was changed to a new one.No impact on patient.
Additional Manufacturer Narrative
Qn # (b)(4).One actual sample was returned for investigation as below.Visual inspection performs found a white tape surround the sample.Cuff able to maintain its pressure at 25mbar.Cuff was then placed under water for water leak test.There is no bubble flowing out from the cuff.This indicates that there is no leakage on the cuff.The side arm and pilot balloon were then placed under water for water leak test.There is no bubble flowing out from the side arm and pilot balloon.This indicates that there is no leakage on the side arm and pilot balloon as well.No bubble flowing out from pilot balloon and side arm.The complaint reported cuff leak during clinical setting before use on patient.One piece of actual sample was returned for investigation.Based on the investigation conducted, defect mode could not be confirmed.There were no bubbles flowing out from cuff, side arm and pilot balloon which indicates no leakage on the tube.

• Brand Name: CURVED REINFORCD CUFF ET
• 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: 15934188
• Report Number: 8040412-2022-00332
• Device Sequence Number: 14567693
• Product Code: BTR
• UDI-Device Identifier: 14026704340917
• UDI-Public: 14026704340917
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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: IPN040964
• Device Catalogue Number: 103902-000045
• Device Lot Number: KME21J1197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown