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

Catalog Number 17732

Device Problem Stretched (1601)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint reported as: the tubing thought to be defective.Tubing came out of package unsafe to use.The anesthesia provider opened the humid-vent to place on the patient's circuit.Upon opening the package, the provider noticed the neck of the device was stretched.It was not used on the patient.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the tubing was stretched.Based on the visual exam, the reported complaint is confirmed.The tube can become stretched if extra force is applied to the tube.At the manufacturing site, a 100% visual exam and leak testing is conducted; therefore, any defect of this type would be detected prior to release.The ifu for this product mentions that this product must be stored in a cool and dry place, protected from light and ozone.Instructions mention to check the system for leakages.

Event Description

Complaint reported as: the tubing thought to be defective.Tubing came out of package unsafe to use.The anesthesia provider openend the humid-vent to place on the patient's circuit.Upon opening the package, the provider noticed the neck of the device was stretched.It was not used on the patient.

• Brand Name: HUDSON HUMID-VENT 2S FLEX,CLEAN
• Type of Device: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 8974385
• MDR Text Key: 156897139
• Report Number: 8040412-2019-00241
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

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: 17732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED; NONE REPORTED