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

Catalog Number 11012

Device Problems Obstruction of Flow (2423); Blocked Connection (2888)

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

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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 ".

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 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
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18786898
• MDR Text Key: 336289576
• Report Number: 8040412-2024-00047
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K952084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2022
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.