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

Catalog Number	111782-000070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the inflation line was founded broken during the test".No patient involvement.
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the inflation line was founded broken during the test".No patient involvement.
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 the investigation, the defect mode on inflation line was found broken matches with complainant report as hole found on the inflation tube.After this process, the tubes with inflated cuffs are hang at slow bertha for 30minutes to check any leak on cuff or other area.Such a noticeable defect (hole at inflation tube) would be easily detected and removed, as it would fail all tests at the manufacturing site.Therefore, the complaint cannot be confirmed as a manufacturing related issue." teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: TRACHEAL TUBE, CUFFED, NASAL PREFORMED
• 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: 21266165
• Report Number: 8040412-2025-00023
• Device Sequence Number: 17054499
• Product Code: BTR
• UDI-Device Identifier: 04026704325658
• UDI-Public: (01)04026704325658(11)240226(17)290131(10)40E24B4787(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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 111782-000070
• Device Lot Number: 40E24B4787
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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