MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID-VENT FILTER COMPACT STRAIGHT; FILTER, BACTERIAL, BREATHING-C

Model Number	IPN043768
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that there was "water leaking in the hme filter while attached to the ventilator and patient.Occured during ventilation treatment.The filter was replaced." at the time of this report, the customer has not returned our requests for additional information.The complaint file will be updated if further information is received.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "the complaint reported that water leaking in the hme filter while attached to the ventilator and patient.Leaking occurred during ventilation treatment.No issue found on the returned complaint sample.Device was assembled correctly.Based on the investigation conducted on the returned sample, the complaint on water leak was not confirmed.Leak test conducted on complaint sample and the result show no leak.Water leaking during ventilation treatment may due to the accumulation of secretion on the filter.Ifu state that replace unit immediately if soiled with secretion or otherwise obstructed.In current manufacturing procedure, 100% leak testing and visual inspection after assembly process is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having leak to be released for shipment." the complaint could not be confirmed.No issues were found with the returned sample and a review of the device history records showed no relevant findings.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that there was "water leaking in the hme filter while attached to the ventilator and patient.Occured during ventilation treatment.The filter was replaced." additional information received indicates there was no delay in patient treatment.

• Brand Name: HUMID-VENT FILTER COMPACT STRAIGHT
• Common Device Name: FILTER, BACTERIAL, BREATHING-C
• 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: 16765572
• Report Number: 8040412-2023-00149
• Device Sequence Number: 17650825
• Product Code: CAH
• UDI-Device Identifier: 04026704348022
• UDI-Public: 04026704348022
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 03/31/2023

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: 01/28/2026
• Device Model Number: IPN043768
• Device Catalogue Number: 19402
• Device Lot Number: KMZ21B1091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2021
• 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