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

Catalog Number 19912

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that the device did not pass the leak test.

Manufacturer Narrative

(b)(4).The actual complaint sample was not returned for evaluation; therefore, ten pieces of the same catalog number in current production at the manufacturing facility were taken to test the reported defect.No defects were found on the samples.Leak testing was also conducted and all samples passed the test.In the current manufacturing procedure, 100% leak testing is conducted at the assembly area; therefore, any defects would be detected prior to release.The reported complaint could not be confirmed as the actual sample was not returned for evaluation.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the device did not pass the leak test.

• Brand Name: HUDSON HUMID-FLO HME
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• 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: 5716991
• MDR Text Key: 47129135
• Report Number: 8040412-2016-00118
• 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: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2016
• 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