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

Model Number	IPN041458
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "during a procedure on wisdom teeth, the cuff was found to be punctured.The patient had to be reintubated".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "one sample was received.The 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 returned sample was inflated to 25 mbar by using calibrated endotest.The observation shows that the cuff was unable to maintain its pressure at 25 mbar.Further inspection carried out on cuff, and it was observed that there is crack line on the cuff.The crack line on the cuff prevents the cuff from inflating.Based on our standard production method such crack line would be detectable during the 100% leak test conducted during inspection and will be rejected immediately.No dimensional inspection was performed as a part of this complaint investigation.A device history record review was not completed as the lot number was unknown.The actual root cause cannot be identified as a manufacturing-related issue since the obvious defect of crack line on cuff of the returned sample, can be detected during 100% inflation test at and visual inspection.No corrective action initiated due to visual inspection on inflation and deflation was 100% conducted in manufacturing process and such obvious defect able to be detected and taken out as it will fail all the testing at manufacturing site.Based on investigation, the defect mode on cuff was punctured matched with the complainant report.There is crack line on cuff observed on the returned sample that prevented the cuff from inflating.However, all the tube will undergo 100% visual inspection and inflation test to check any leak and other defect.After this process, the tubes with inflated cuffs are hang at hanging jig for 30minutes to check any leak on cuff.Such a noticeable defect (the crack line on the cuff) would be easily detected and removed, as it would fail all tests at the manufacturing site.Therefore, the complaint cannot be confirmed as it is not a manufacturing related issue." teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during a procedure on wisdom teeth, the cuff was found to be punctured.The patient had to be reintubated".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: RUSCHELIT TRACHEAL TUBE, CUFFED
• 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: 21451270
• Report Number: 8040412-2025-00058
• Device Sequence Number: 7196344
• Product Code: BTR
• UDI-Device Identifier: 04026704325641
• UDI-Public: (01)04026704325641(11)240816(17)290731(10)40E24H2606(21)
• Combination Product (Y/N): N
• 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): 02/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: IPN041458
• Device Catalogue Number: 111782-000060
• Device Lot Number: UNKNOWN
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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