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

Catalog Number	11012
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "healthcare clinician used a humid-vent pedi filter on a patient in the day clinic and was unable to obtain a co2 reading on the capnograph.Clinical consequences: the filter was replaced and the dr was the able to obtain the desired reading.".
Event or Problem Description
It was reported that: "healthcare clinician used a humid-vent pedi filter on a patient in the day clinic and was unable to obtain a co2 reading on the capnograph.Clinical consequences: the filter was replaced and the dr was the able to obtain the desired reading.".
Additional Manufacturer Narrative
Qn # (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "complaint reported that doctor was unable to obtain a co2 reading on the capnograph.Based on the investigation conducted on the returned sample, luer port of the complaint product housing has occluded by the housing material.One actual sample was received.The sample was closely examined by visual inspection.The result of visual inspection is that the luer port is occluded.The mentioned product housing was supplied by our supplier.Assembly process will be conducted in our manufacturing site for the product after they receive the part item from supplier.A device history record review was performed, and no relevant findings were identified.A new non-conformance was raised to further investigate on this issue.Based on the investigation conducted on the returned sample, this complaint is confirmed.The mentioned product housing was supplied by our supplier and is out of the scope from previous supplier corrective action requests and hence, a non-conformance has been issued and root cause analysis and identified corrective actions will be implemented." teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "healthcare clinician used a humid-vent pedi filter on a patient in the day clinic and was unable to obtain a co2 reading on the capnograph.Clinical consequences: the filter was replaced and the dr was the able to obtain the desired reading".

• 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: 18993202
• Report Number: 8040412-2024-00083
• Device Sequence Number: 15341232
• 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): 03/01/2024

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: 11012
• Device Lot Number: 40Z23K3185
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 04/19/2024; Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/23/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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