MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HV TRACH; CONDENSER, HEAT AND MOISTURE

Catalog Number	41112
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the user was unable to connect the oxygen port of the trach-vent to the tracheostomy tube during use, as the connection was too loose.It occurred to 2 units in a row, to the same patient.Therefore, a new unit of the different lot# (lot#: unknown) was used to complete the procedure.No injury to the patient occurred".
Event or Problem Description
It was reported that "the user was unable to connect the oxygen port of the trach-vent to the tracheostomy tube during use, as the connection was too loose.It occurred to 2 units in a row, to the same patient.Therefore, a new unit of the different lot# (lot#: unknown) was used to complete the procedure.No injury to the patient occurred".
Additional Manufacturer Narrative
(b)(4) fifteen (15) samples were returned in their original packaging.2 original hme samples were returned, and 13 representative samples were returned.However, all 15 samples were opened and returned in a single package.As a result, the original samples and representative samples could not be distinguished.Therefore, all samples will be investigated together.Upon visual inspection, no abnormalities were observed on the hme filters.A functional test was performed to evaluate the connection between the hme filter and the product.All 15 samples were labeled from 1 to 15.A standard production tracheostomy tube was then inserted into the trach-vent housing at the designated opening for each sample.The connection between the hme filters and the stand-ard tracheostomy tube was found to be secure for all samples, with no evidence of looseness, disengagement, or detachment.Therefore, the complaint of loose trach ve nt is not confirmed.The device history record for lot number was reviewed and no issue related to complaint was noted.The device was manufactured according to release specification.Fifteen samples were returned in their original packaging.Functional testing confirmed no evidence of looseness, disengagement, or detachment.Therefore, the complaint of loose trach vent is not confirmed.Other remarks: n/a corrected data: n/a.

• Brand Name: HV TRACH
• Common Device Name: CONDENSER, HEAT AND MOISTURE
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24931141
• Report Number: 8040412-2026-00046
• Device Sequence Number: 21499776
• Product Code: BYD
• UDI-Device Identifier: 14026704929846
• UDI-Public: (01)14026704929846(11)240612(17)290531(10)40Z24F2091(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 41112
• Device Lot Number: 40Z24F2091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown