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

Model Number IPN042781

Device Problem Material Separation (1562)

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

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the doctor found tube rupture when using on patient and changed new one".No patient injury or harm reported.Patient condition reported as "fine".

Event Description

It was reported that "the doctor found tube rupture when using on patient and changed new one".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided a video for evaluation.The video was reviewed and it was confirmed that the tubing was torn.The manufacturing site reports: based on the observation, this complaint is confirmed.The defect part was supplied by our supplier.In manufacturing, a non-conformance (nc) has been raised to address this issue and root causes with corrective actions will be implemented through this nc process.

• Brand Name: HUDSON HUMID-VENT 2S FLEX DC CLEAN
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14052610
• MDR Text Key: 289353710
• Report Number: 8040412-2022-00075
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 04026704347926
• UDI-Public: 04026704347926
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN042781
• Device Catalogue Number: 17732
• Device Lot Number: KMZ21D0016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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