MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMID-FLO HME; CONDENSER, HEAT AND MOISTURE (

Catalog Number 19912

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges the respiratory therapist states the device connection is loose and thus disconnects easily during patient use.

Manufacturer Narrative

(b)(4).The actual sample was not returned; therefore ten pieces of the same catalog number were taken from current production at the manufacturing facility to test the reported defect.All ten samples passed visual and leak testing.In addition, a plug test gauge and ring gauge test were conducted on the ten production samples to spot if the diameter of humid-flo connector which connects to the ventilator circuit or patient is out of specification.Both sides met the specification.A device history record review was performed and no relevant findings were identified.Without the actual 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 respiratory therapist states the device connection is loose and thus disconnects easily during patient use.

• Brand Name: HUDSON HUMID-FLO HME
• Type of Device: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7677466
• MDR Text Key: 113752467
• Report Number: 8040412-2018-00179
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 19912
• Device Lot Number: 201806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2018
• 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