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

Model Number	IPN041702
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that prior to use, "impossible to connect the syringe with the blue cuff, therefore impossible to use." no patient involvement.The issue was resolved by using a new device of the same brand.No impact to the patient.
Event or Problem Description
It was reported that prior to use, "impossible to connect the syringe with the blue cuff, therefore impossible to use." no patient i involvement.The issue was resolved by using a new device of the same brand.No impact to the patient.
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as no sample was returned for analysis.With no original sample returned for investigation, a representative sample was retrieved from production lot for simulation purpose.Visual inspection was conducted on the production representative sample and no obvious defects were identified.The cuff pressure of the production representative sample was then inflated to 25mbar by using calibrated endotesta.No abnormality was observed when connecting the endotesta to the inflation valve.The complaint was unable to be further investigated and the root cause could not be determined due to no sample returned.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that prior to use, "impossible to connect the syringe with the blue cuff, therefore impossible to use." no patient i nvolvement.The issue was resolved by using a new device of the same brand.No impact to the patient.
Additional Manufacturer Narrative
(b)(4).The reported complaint of 'impossible to connect the syringe with the blue cuff could not be confirmed based upon the sample received.The bespak valve able to connect with syringe.As part of functional inspection, the bronchial tube was connected and was inflated using calibrated endotesta for both clear and blue cuff and the cuffs were able to maintain pressure at 25mbar.A device history record review was performed, and no relevant findings were identified.The probable cause of this complaint issue could not be determined as there is no failure found from the returned sample.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17363311
• Report Number: 8040412-2023-00300
• Device Sequence Number: 5205755
• Product Code: CBI
• UDI-Device Identifier: 14026704344243
• UDI-Public: 14026704344243
• 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,Followup
• Report Date (Section B): 07/04/2023

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: IPN041702
• Device Catalogue Number: 116100390
• Device Lot Number: KME23A1101
• 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: 07/04/2023
• Supplement Date Received by Manufacturer: 08/22/2023; 10/03/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/24/2023; 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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