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

Catalog Number	111782-000070
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "upon inspection and prior to use it was noticed that the cuff would not inflate due to there being a hole in the cuff.".
Additional Manufacturer Narrative
Qn# (b)(4).The reported defect of "cuff was found, hole in the cuff" was confirmed upon investigation of the returned sample.The customer returned the actual sample for evaluation.Visual inspection on the sample revealed an obvious cuff tear.Functional inspection identified that the cuff failed to inflate during the inflation test which was traced to a large tear on the cuff.A review of the manufacturing process confirmed that tracheal tubes undergo 100% inspection, inflation and deflation test as part of the product release criteria.Any obvious defects as per returned sample 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 defect could not be attributed to manufacturing issues.Additionally, a device history record was conducted and no issue related to complaint was noted.The device was manufactured according to release specification.It is possible that the damage was caused by external or excessive physical force, however the exact root cause could not be determined.
Event or Problem Description
It was reported that: "upon inspection and prior to use it was noticed that the cuff would not inflate due to there being a hole in the cuff.".

• Brand Name: RUSCH 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22094647
• Report Number: 8040412-2025-00139
• Device Sequence Number: 6947463
• Product Code: BTR
• UDI-Device Identifier: 04026704325658
• UDI-Public: (01)04026704325658(11)240226(17)290131(10)40E24B4784(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 05/04/2025

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: 40E24B4784
• 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: 05/04/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED
• Patient Sex: Unknown