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

Model Number	IPN041700
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that prior to use in the clinical setting the "bronchoscope does not go through the endobronchial tube while inserte d." the clinicians used another device instead from a different manufacturer to complete the procedure.No impact to the patient.No patient involvement.
Event or Problem Description
It was reported that prior to use in the clinical setting the "bronchoscope does not go through the endobronchial tube while inserted".The clinicians used another device instead from a different manufacturer to complete the procedure.No impact to the patient.No patient involvement.
Additional Manufacturer Narrative
(b)(4).The device was returned and sent to the manufacturing site for investigation.The manufacturing site reports the complaint was confirmed as it was found there was a blockage in the bronchial connector.A non-conformance was opened to further investigate this issue.Other remarks: n/a.Corrected data: n/a.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17326618
• Report Number: 8040412-2023-00294
• Device Sequence Number: 20217988
• Product Code: CBI
• UDI-Device Identifier: 14026704344229
• UDI-Public: 14026704344229
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141888
• 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): 06/22/2023

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: IPN041700
• Device Catalogue Number: 116100350
• Device Lot Number: KM22M0597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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 Sex: Unknown