MAUDE Adverse Event Report: PORTEX; BREATHING-CIRCUIT

Model Number C45041345-NLJ

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

It was reported that during a pre-use check, the customer noticed air was leaking from the anesthesia circuit.No patient injury.

Manufacturer Narrative

Device evaluation- one device sample was returned for evaluation.The examination of the device showed no discrepancies.The device was given functional testing and found to leak.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.The cause of the issue was not definitely established.

• Brand Name: PORTEX
• Type of Device: BREATHING-CIRCUIT
• MDR Report Key: 10912747
• MDR Text Key: 218648490
• Report Number: 3012307300-2020-11853
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: C45041345-NLJ
• Device Catalogue Number: C45041345-NLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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