MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXACTAMIX 2000 ML EVA CONTAINER; SET, I. V. FLUID TRANSFER

Catalog Number H938740

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 07/31/2018

Event Type  malfunction  

Event Description

The middle port of the exactamix 2000 ml eva container has a hole.The leak was discovered after the bag was filled.Dates of use: (b)(6) 2018.

• Brand Name: EXACTAMIX 2000 ML EVA CONTAINER
• Type of Device: SET, I. V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 7776602
• MDR Text Key: 117130956
• Report Number: MW5079060
• Device Sequence Number: 1
• Product Code: NEP
• 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: 08/07/2018

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: 09/01/2020
• Device Catalogue Number: H938740
• Device Lot Number: 60095450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1