MAUDE Adverse Event Report: TELEFLEX MEDICAL HUMID-VENT; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Lot Number 201653

Device Problem Material Integrity Problem (2978)

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

Event Date 06/08/2017

Event Type  malfunction  

Event Description

(b)(6) has identified an issue w/ the teleflex humid-vent.White flakes coming out of the coils were noted within lot # 201653.This issue has not been found to be consistent within this lot number.Manufacturer response for teleflex humid-vent, teleflex humid-vent (per site reporter): the lot number has been pulled from the self and the teleflex rep.Will be coming to hospital to pick-up the teleflex humid-vent with the lot # 201653.

• Brand Name: HUMID-VENT
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 6683924
• MDR Text Key: 78956305
• Report Number: 6683924
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 201653
• Other Device ID Number: #14412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO