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

Lot Number 60105416

Device Problems Leak/Splash (1354); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 12/21/2018

Event Type  malfunction  

Event Description

The bottom of the exactamix 500 ml eva container has not been heat-sealed properly and contents of the container had spilled all over hood during compounding.This is the 6th bag from the same lot number with a product problem, and the other 5 were middle port leaking issues.Dates of use: (b)(6) 2018.

• Brand Name: EXACTAMIX 500 ML EVA CONTAINER
• Type of Device: SET, I.V, FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 8213789
• MDR Text Key: 132338182
• Report Number: MW5082813
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/01/2021
• Device Lot Number: 60105416
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1