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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.
Event or Problem Description
It was reported that "upon inspection and prior to use it was noticed that the cuff would not inflate." associated complaints 8040412-2025-00088 and 8040412-2025-00086.
Event or Problem Description
It was reported that "upon inspection and prior to use it was noticed that the cuff would not inflate." associated complaints 804041 2-2025-00088 and 8040412-2025-00086.
Additional Manufacturer Narrative
(b)(4).The reported defect 'the cuff would not inflate' was confirmed upon investigation of the returned sample.The customer returned the actual sample for investigation.Visual inspection revealed a tear on the cuff.Functional inspection revealed that the cuff was unable to inflate and maintain its pressure at 25 mbar.The large tear on the cuff prevents the cuff from inflating.An examination of the manufacturing procedures indicated that all tracheal tubes undergo 100% visual inspection, inflation and deflation test conducted during inspection and any out of specification would be detected and rejected as part of product release criteria.A device history record review was performed, and no relevant findings were identified.It is possible that the damage resulted from external or excessive physical force, however the exact root cause of this issue could not be determined.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21696566
• Report Number: 8040412-2025-00086
• Device Sequence Number: 15636031
• 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,Followup
• Report Date (Section B): 03/07/2025

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: 03/07/2025
• Supplement Date Received by Manufacturer: 04/27/2025; 07/04/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/02/2025; 07/08/2025
• 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