MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID-VENT FILTER PEDI; CONDENSER, HEAT AND MOISTURE (

Catalog Number	11012
Medical Device Problem Codes	Obstruction of Flow (2423); Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " absent capnography trace despite being able to ventilate the patient.On inspection, no opening between the capnography port and the filter ".
Additional Manufacturer Narrative
(b)(4).The sample was not returned to the manufacturer for investigation.The manufacturer reported: "no sample was returned for investigation.However, customer has provided a photo.Complaint reported that no opening between the capnography port and the filter.Based on the photo provided, the actual reported defect was not identified.The testing method shows in the photo provided may not suitable to check on the co2 port functionality.Further investigation could not be conducted to identify the root cause of defect on the complaint sample since there is no returned sample.In current manufacturing procedure, 100% visual inspection, drop test and leak test after assembly process is conducted.No sample was returned for investigation and only photo is provided.Thus, full investigation on the reported failure could not be conducted to identify the actual root cause of the reported phenomenon.Therefore, this complaint is not confirmed." teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported that " absent capnography trace despite being able to ventilate the patient.On inspection, no opening between the capnography port and the filter ".
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "one actual sample was received.The sample was closely examined by visual inspection.Per visual inspection, the luer port was occluded.Complaint reported no opening between the capnography port and the filter.Based on the investigation conducted on the returned sample, luer port of the complaint product housing has occluded by the housing material.The mentioned product housing was supplied by our supplier and hence a non-conformance has been issued.The root cause analysis and identified corrective actions was implemented.A device history record review was performed, and no relevant findings were identified.Based on the investigation conducted on the returned sample, this complaint is confirmed." teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " absent capnography trace despite being able to ventilate the patient.On inspection, no opening between the capnography port and the filter ".

• Brand Name: HUMID-VENT FILTER PEDI
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18786898
• Report Number: 8040412-2024-00047
• Device Sequence Number: 8352227
• Product Code: CAI
• UDI-Device Identifier: 04026704347841
• UDI-Public: 04026704347841
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K952084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2024

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
• Device Catalogue Number: 11012
• Device Lot Number: KMZ22L0074
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 03/29/2024; 06/10/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/01/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown