MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Model Number IPN913681

Device Problems Stretched (1601); Device Damaged Prior to Use (2284)

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

Event Date 07/08/2019

Event Type  malfunction  

Event Description

The tubing thought to be defective.Tubing came out of package unsafe to use.The anesthesia provider opened the humidi-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 RCI
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill boulevard; morrisville NC 27560
• MDR Report Key: 8860230
• MDR Text Key: 153267224
• Report Number: 8860230
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN913681
• Device Catalogue Number: 14412-BQY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1