MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RU¨SCH AGT NASAL CUFFED ET 5.0MM; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	111781050
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "during a dental case the et tube was removed they noticed a hole in the tube.Only 1 was used on a patient, the others were not used on patients.Once they realized there was a hole, they checked the remaining products in the box and discovered that they all had holes.Issue was resolved by using a tube from another box/lot the next time.No patient harm or consequence." associated complaints 8040412-2026-00013.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during a dental case the et tube was removed they noticed a hole in the tube.Only 1 was used on a patient, the others were not used on patients.Once they realized there was a hole, they checked the remaining products in the box and discovered that they all had holes.Issue was resolved by using a tube from another box/lot the next time.No patient harm or consequence." associated complaints 8040412-2026-00013 and 8040412-2026-00010.
Additional Manufacturer Narrative
(b)(4) the reported issue of hole in tube could not be confirmed upon investigation of the returned packaging.The customer returned only the packaging.The physical sample was not available for evaluation.However, picture evidence was provided by the customer, but the image was blurred in nature and did not allow clear visualization of the alleged defect.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.

• Brand Name: RU¨SCH AGT NASAL CUFFED ET 5.0MM
• 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: 24257233
• Report Number: 8040412-2026-00010
• Device Sequence Number: 8309823
• Product Code: BTR
• UDI-Device Identifier: 14026704341181
• UDI-Public: (01)14026704341181(11)250615(17)300531(10)40E25F2359(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 111781050
• Device Lot Number: 40E25F2359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/15/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED
• Patient Sex: Unknown