MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCHELIT TRACHEAL TUBE, CUFFED, NASAL PREFORM; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	111782-000060
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the air leaking was found in the late phase of surgery, and doctor retracted it.Patient was fine".At the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer for evaluation.The manufacture reported: "one actual sample was received in an open pouch for further evaluation.Visual inspection was conducted on the received sample and no abnormalities were observed.No dimensional inspection was performed as part of this complaint investigation.The cuff pressure of the actual investigation.The cuff pressure of the actual returned sample was inflated to 25mbar by using calibrated endotest.The observation shows that the cuff was unable to maintain its pressure at 25mbar.Further inspection carried out and it was observed that there is a hole on inflation tube of side arm.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 air leaking was found in the late phase of surgery matched with the complainant report.There was cut mark observed on the cuff that prevented the cuff from inflating.However, visual inspection on inflation and deflation was 100% conducted during manufacturing process and such obvious defect able to be detected and taken out as it will fail all the testing at manufacturing site.Thus, this defect could not be determined as manufacturing related, and the complaint is not confirm." teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the air leaking was found in the late phase of surgery, and doctor retracted it.Patient was fine." at the time of this report, the customer has not returned our requests for additional information.

• Brand Name: RUSCHELIT TRACHEAL TUBE, CUFFED, NASAL PREFORM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• 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: 21323451
• Report Number: 8040412-2025-00028
• Device Sequence Number: 18293589
• Product Code: BTR
• UDI-Device Identifier: 04026704325634
• UDI-Public: (01)04026704325634(11)240315(17)290228(10)40E24C2623(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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 Catalogue Number: 111782-000060
• Device Lot Number: 40E24C2623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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