MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH BRONCHOPART DLT LEFT, CARINA HOOK; TUBE, BRONCHIAL (W/WO CONNECT

Model Number	IPN047059
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the incident occurred during extubation.After deflating both balloons (with both pilot balloons deflated) the tracheal balloon was still inflated.Both balloons had blood on them".At the time of this report, the customer has not returned our requests for additional information.
Event or Problem Description
It was reported that "the incident occurred during extubation.After deflating both balloons (with both pilot balloons deflated) the tracheal balloon was still inflated.Both balloons had blood on them".At the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "one actual sample was received in an open pouch for further evaluation.Visual inspection was conducted on the received sample and based on the inspection we did not find any abnormalities.The cuff pressure of the actual returned sample was inflated to 25mbar by using calibrated endotest and was then deflated to see its ability to deflate.The bronchial blue cuff was able to maintain its pressure at 25mbar and it was able to deflate easily.The tracheal clear cuff was able to maintain its pressure at 25mbar and it was able to deflate easily.Based on the results of the test conducted, it was observed that both clear cuff and the blue cuff were able to inflate and also deflate without any restriction.The sample was then subjected to a water leak test to further assess the presence of any leakage in the returned sample.In the bronchial blue cuff, no presence of bubble was observed during water leak test.In the tracheal clear cuff, no presence of bubble was observed during water leak test.The device history record was reviewed and no issue related to complaint was noted.The device was manufactured according to release specification.Based on investigation, the defect mode on cuff could not deflate did not matches with complainant report.The blue and clear cuff could inflate as well as deflate during inflation and deflation test and there are no bubbles observed during water leak test.For the non-deflation issue which customer claimed, there is a 100% deflation conducted using deflation machine during manufacturing and any non-deflated cuff will be discarded.100% visual inspection also conducted to ensure all cuff fully deflated before packing process in accordance with the standard production method.Any obvious defects as per customer claimed that do not meet the quality assurance specification should have been detected and rejected, as they would fail all tests at the manufacturing site.Therefore, this complaint is not confirmed and could not be attributed to manufacturing issues.No root cause identified as no abnormalities observed from the returned sample since the inflation and also the deflation can be done without any issue." teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH BRONCHOPART DLT LEFT, CARINA HOOK
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20771984
• Report Number: 8040412-2024-00265
• Device Sequence Number: 14556105
• Product Code: BTS
• UDI-Device Identifier: 14026704344298
• UDI-Public: (01)14026704344298(11)240529(17)290430(10)40E24E4443(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K951091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN047059
• Device Catalogue Number: 116101-000410
• Device Lot Number: 40E24E4443
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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