MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 2000 ML EVA CONTAINER; SYSTEM / DEVICE, PHARMACY, COMPOUNDING

Lot Number 60126020

Device Problem Material Puncture/Hole (1504)

Patient Problem No Information (3190)

Event Date 10/15/2018

Event Type  malfunction  

Event Description

There is a hole in the middle of the 2l exactamix eva container.Dates of use: (b)(6) 2018.

• Brand Name: 2000 ML EVA CONTAINER
• Type of Device: SYSTEM / DEVICE, PHARMACY, COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 8084780
• MDR Text Key: 128034140
• Report Number: MW5081432
• 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: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 60126020
• 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