MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX 500 ML EVA CONTAINER ; SYSTEM / DEVICE, PHARMACY COMPOUNDING

Lot Number 60187198

Device Problem Leak/Splash (1354)

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

Event Date 02/06/2020

Event Type  malfunction  

Event Description

There is a leak in the port with the green clip of the exactamix 500 ml eva container.This occurred during med production and did not reach pt interaction.

• Brand Name: EXACTAMIX 500 ML EVA CONTAINER
• Type of Device: SYSTEM / DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 9699775
• MDR Text Key: 179312699
• Report Number: MW5092949
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2022
• Device Lot Number: 60187198
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1