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

Catalog Number	111781050
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
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 identified in inventory.No patient involved" associated complaints 8040412-2026-00010.
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 identified in inventory.No patient involved" associated complaints 8040412-2026-00013 and 8040412-2026-00010.
Additional Manufacturer Narrative
(b)(4).Per communication with consumer safety officer from the fda on 22jun2022, for large quantity complaints, ensure one report is received for each lot number reported.One mdr report will be sent for the reported quantity of 9 eaches.Device evaluation: the reported complaint of hole in tube was confirmed upon investigation of the returned sample.The customer returned nine representative samples for evaluation.One out of the 9 samples exhibited a hole at the second notch of the tube.A review of the manufacturing process confirmed that a 100% visual inspection is performed to detect defects related to improper inflation hole punching, as part of product release criteria.Any hole punched through the tube wall is classified as a reject condition per the acceptance criteria.A device history record review was performed, and no relevant findings were identified.Since the product was unused and the pouch remained unopened at the time of return, it is confirmed that the issue is attributed to a manufacturing-related cause.Further investigation has been initiated under teleflex quality systems to evaluate this issue.

• Brand Name: 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: 24257201
• Report Number: 8040412-2026-00013
• Device Sequence Number: 8326724
• 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): 01/13/2026

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: 01/13/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• 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
• Patient Sex: Unknown