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

Catalog Number 17732

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown whether the device is available for evaluation at this time.Teleflex has requested this information.Customer submitted photos for review.The investigation of this complaint is still in progress at the time of this initial report.

Event Description

Customer complaint alleges the device developed a "laceration" across the plastic between the hard plastic end connecting to the endotracheal tube and the beginning of the softer plastic ridges".Alleged defect reported detected during use.There was no report of patient impact or consequence.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; however, the customer did provide a picture.Based on the review of the photo, the product tubing was torn.This may happen during mishandling of the product during use.At the manufacturing site, a 100% inspection and leak testing is performed; therefore, any defects would be detected prior to release.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 complaint alleges the device developed a "laceration" across the plastic between the hard plastic end connecting to the endotracheal tube and the beginning of the softer plastic ridges".Alleged defect reported detected during use.There was no report of patient impact or consequence.

• 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: 7797235
• MDR Text Key: 117607027
• Report Number: 8040412-2018-00215
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 10/05/2018
• Supplement Dates FDA Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOTRACHEAL TUBE; ENDOTRACHEAL TUBE; ENDOTRACHEAL TUBE