MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH AGT NASAL CUFFED ET 4.5MM; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	111781045
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction

• Brand Name: RUSCH AGT NASAL CUFFED ET 4.5MM
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 50286448
• Report Number: 8040412-2026-00133
• Device Sequence Number: 16133428
• Product Code: BTR
• UDI-Device Identifier: 14026704341174
• UDI-Public: (01)14026704341174(11)251031(17)300930(10)40E25K6099
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K931164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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: 111781045
• Device Lot Number: 40E25K6099
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2025
• 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