MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HV TRACH; HUMID-VENT HEAT AND MOISTURE

Model Number	IPN044386
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the "filters on either side of the artificial noses for tracheostomy patients were full with secretions and fell off.When patients cough, the filters also fall down".As a result, the device was changed out for another.No patient harm or injury.
Event or Problem Description
It was reported that the "filters on either side of the artificial noses for tracheostomy patients were full with secretions and fell off.When patients cough, the filters also fall down".As a result, the device was changed out for another.No patient harm or injury.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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: HV TRACH
• Common Device Name: HUMID-VENT 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: 17321200
• Report Number: 8040412-2023-00284
• Device Sequence Number: 15179183
• Product Code: BYD
• UDI-Device Identifier: 04026704348145
• UDI-Public: 04026704348145
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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 Expiration Date: 08/28/2025
• Device Model Number: IPN044386
• Device Catalogue Number: 41112
• Device Lot Number: KMZ20J0106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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