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

Catalog Number	41112
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction

• 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: edel connelly ; ida business and technology park, dublin rd; athlone 27560 ; EI 27560
• MDR Report Key: 50058854
• Report Number: 8040412-2026-00114
• Device Sequence Number: 9211989
• Product Code: BYD
• UDI-Device Identifier: 14026704929846
• UDI-Public: (01)14026704929846(11)240612(17)290531(10)40Z24F1918
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 40Z24F1918
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/17/2026
• 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
• Patient Sex: Unknown