MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUSON HUMID-VENT 2S FLEX,STERILE; CONDENSER, HEAT AND MOISTURE (

Catalog Number 17731

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the device was malfunctioning while being used on patients.Additional information was requested, but not available at the time of this report.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.In the current manufacturing procedure 100% leak testing and drop testing are conducted at the assembly area; thus, any defective product would be detected prior to release from the manufacturing facility.Ten pieces of the same product were taken from current production at the manufacturing facility and testing was conducted.All samples were assembled correctly and passed leak and drop testing.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.

Event Description

Customer reported the device was malfunctioning while being used on patients.Additional information was requested, but not available at the time of this report.

• Brand Name: HUSON HUMID-VENT 2S FLEX,STERILE
• Type of Device: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10200360
• MDR Text Key: 197166824
• Report Number: 8040412-2020-00140
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

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: No Information
• Device Catalogue Number: 17731
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.