MAUDE Adverse Event Report: TELEFLEX MEDICAL DOUBLE LUMEN BRONCHIAL TUBE SET LEFT

Model Number	IPN041701
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: prior to use, during the test of the endobronchial cannula, it was noticed that the cuff was perforated and it was necessary to replace the product.
Additional Manufacturer Narrative
(b)(4).During the test of the endobronchial cannula, it was noticed that the cuff was perforated, and it was necessary to replace the product.Trend review for the last 5 years on the same defect type and catalogue number/product type shows 100% leak test was conducted and no leak product was found.The photograph received for this complaint did not clearly show the perforation as reported therefore, we could not confirm the defect as per description.Since there is no sample returned for investigation, one set of representative samples was retrieved from production lot for simulation purpose.A visual inspection was conducted on the production representative sample and no obvious defect was observed.The cuff pressure of the production representative sample was then inflated to 25mbar by using calibrated endotest.No abnormality was observed on the sample.A water leak test was then conducted on the sample and no air bubbles were observed flowing out from both cuffs.There is no issue found from the simulation test.The complaint was unable to be further investigated due to no sample returned.The photograph received for this complaint did not clearly show the perforation as reported therefore we could not confirm the defect as per description.
Event or Problem Description
Reported issue: prior to use, during the test of the endobronchial cannula, it was noticed that the cuff was perforated and it was necessary to replace the product.

• Brand Name: DOUBLE LUMEN BRONCHIAL TUBE SET LEFT
• Common Device Name: BRONCHIAL TUBE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• 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: 16035913
• Report Number: 8040412-2022-00348
• Device Sequence Number: 20639185
• Product Code: CBI
• UDI-Device Identifier: 14026704344236
• UDI-Public: 14026704344236
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141888
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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 Expiration Date: 06/28/2026
• Device Model Number: IPN041701
• Device Catalogue Number: 116100370
• Device Lot Number: KME21G1365
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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