MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXACTAMIX 500 ML EVA CONTAINER; SET, I.V. FLUID TRANSFER

Device Problems Fluid/Blood Leak (1250); Device Markings/Labelling Problem (2911)

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

Event Date 02/04/2020

Event Type  malfunction  

Event Description

Exactamx 500 ml eva container has a leak in the port with the green clip.This occurred during medication production and did not have any patient interaction.The lot number and expiration date are illegibly faded on the bag.

• Brand Name: EXACTAMIX 500 ML EVA CONTAINER
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 9686687
• MDR Text Key: 178608431
• Report Number: MW5092856
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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