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

Catalog Number 11012

Device Problem Obstruction of Flow (2423)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that : "the device was discovered to have a partially blooked port.There was no co2 trace when expected, isolated fault to hme, noticed sampling port lumen was blocked." additional information: there was no health consequences to the patient and no desaturations.

Manufacturer Narrative

(b)(4).The sample was returned to the manufacturer.The manufacturer reported: "visual, dimensional, and functional inspection could not be conducted as no physical complaint sample was returned for investigation.Thus, this complaint could not be confirmed." teleflex will continue to monitor and trend complaints of this nature.

Event Description

It was reported that : "the device was discovered to have a partially blocked port.There was no co2 trace when expected, isolated fault to hme, noticed sampling port lumen was blocked." additional information: there was no health consequences to the patient and no desaturations.

• 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: 18874122
• MDR Text Key: 337309997
• Report Number: 8040412-2024-00076
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 40Z23D8189
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2023
• 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
• Treatment: NOT REPORTED; NOT REPORTED