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

Lot Number 60145459

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2019

Event Type  malfunction  

Event Description

The left port of the exactamix 500 ml eva container does not connect to the bag.It appears to be heat sealed incorrectly.This was discovered during use, but before any patient interaction.Dates of use: (b)(6) 2019.Is the product compounded? no.Is the product over-the-counter? no.

• Brand Name: EXACTAMIX 500ML EVA CONTAINER
• Type of Device: SET I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 8253136
• MDR Text Key: 133543465
• Report Number: MW5083144
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2021
• Device Lot Number: 60145459
• 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