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

Catalog Number 11012

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

The report states that "the filter has a portal which is blocked with a piece of plastic thus occluding it and not allowing the patient's anesthesia circuit to work.It was noticed prior to use on a patient".No patient involvement.

Manufacturer Narrative

Qn#(b)(4).

Event Description

The report states that "the filter has a portal which is blocked with a piece of plastic thus occluding it and not allowing the patient's anesthesia circuit to work.It was noticed prior to use on a patient".No patient involvement.

Manufacturer Narrative

(b)(4).The reported complaint of " blockage in filter prior to 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.

• Brand Name: HUMID-VENT FILTER PEDI
• Type of Device: 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: 17887539
• MDR Text Key: 326024877
• Report Number: 8040412-2023-00358
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 04026704347841
• UDI-Public: 04026704347841
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K952084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 11012
• Device Lot Number: KMZ23B0563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1