MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT; TUBE, BRONCHIAL (W/WO CONNECT

Model Number	IPN041700
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor found cuff leakage when doing clinical setting before using on patient.Then changed new one, no impact on patient".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the doctor found cuff leakage when doing clinical setting before using on patient.Then changed new one, no impact on patient".
Additional Manufacturer Narrative
(b)(4).The actual sample was returned for evaluation.A visual exam was performed and a stain was observed indicating the sample could have been used by the customer.The pressure of the clear cuff and the blue cuff of the device were then tested by inflating the cuffs to 25 mbar using a calibrated endotest.It was observed that the blue cuff was able to maintain pressure at 25mbar; however, the clear cuff would not stay inflated.A water leak test was then conducted on the returned sample by immersing it underwater.Bubbles were observed flowing out from the clear cuff indicating a leak.The area of leakage was observed under magnification and cut marks were observed on the cuff.A device history record review was performed and no relevant findings were identified.The complaint of leakage was confirmed; however, a root cause for the issue could not be determined.There is a 100% inflation and water leak test conducted at the manufacturing facility whereby any leakage would be detected prior to release.It is possible that the failure could be induced during product handling by the user, although this could not be confirmed.Other remarks: n/a.Corrected data: n/a.

• Brand Name: RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECT
• 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: 16809828
• Report Number: 8040412-2023-00195
• Device Sequence Number: 12260190
• Product Code: BTS
• UDI-Device Identifier: 14026704344229
• UDI-Public: 14026704344229
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951091
• 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): 04/06/2023

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: 116100-000350
• Device Lot Number: KME22J0131
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown