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	09/20/2024
Type of Reportable Event	Malfunction
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.Therefore, a new unit was used instead.No injury to the patient was reported".Additional information states that "the issue occurred during the procedure, but before use on the patient.The user was unable to connect the trach-vent to the tube, so he/she did not use it on the patient".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer returned twenty unused devices from the same lot for investigation.A visual exam was performed and no abnormalities were found.A 15mm plug gauge test was also conducted and all samples were found to be within specification.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues identified with the returned devices.Teleflex will continue to monitor and trend for reports of this nature.
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.Therefore, a new unit was used instead.No injury to the patient was reported".Additional information states that "the issue occurred during the procedure, but before use on the patient.The user was unable to connect the trach-vent to the tube, so he/she did not use it on the patient".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20524909
• Report Number: 8040412-2024-00248
• Device Sequence Number: 7969853
• Product Code: BYD
• UDI-Device Identifier: 04026704348145
• UDI-Public: (01)04026704348145(11)230510(17)280430(10)40Z23E1396(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 40Z23E1396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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