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

Catalog Number	11012
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that, "blockage in filter preventing ventilation of pediatric patient.Seems to have plastic inside it causing blockage.Patient was unable to be ventilated.No carbon dioxide reading was obtained.All aspects of circuit were examined.The filter was found to be the cause".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).The reported complaint of " blockage in filter during use" was confirmed based on the evaluation of the actual sample that was received.The sample was closely examined and the luer port was occluded.Complaint reported that plastic inside device causing blockage and no carbon dioxide reading was obtained.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 supplier corrective action request (scar) and nc has been issued, root cause analysis and identified corrective actions will be implemented through this scar.Assembly process will be conducted in our manufacturing site for the product after receive the part item from supplier.Based on the investigation conducted on the returned sample, this complaint is confirmed.The mentioned product housing was supplied by our supplier, and hence supplier corrective action request (scar) and nc has been issued and root cause analysis and identified corrective actions will be implemented through this scar.Teleflex will continue to monitor and trend on reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that, "blockage in filter preventing ventilation of pediatric patient.Seems to have plastic inside it causing blockage.Patient was unable to be ventilated.No carbon dioxide reading was obtained.All aspects of circuit were examined.The filter was found to be the cause".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

• 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: 17897320
• Report Number: 8040412-2023-00355
• Device Sequence Number: 17007881
• Product Code: CAI
• UDI-Device Identifier: 04026704347841
• UDI-Public: 04026704347841
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K952084
• 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): 09/18/2023

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 Catalogue Number: 11012
• Device Lot Number: 40Z23D8189
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2023
• 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