MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXACTAMIX 2 L EVA CONTAINER

Lot Number 60098865

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 01/26/2018

Event Type  malfunction  

Event Description

There is a small pin-sized hole along the bottom right seam of the exactamix 2 l eva container.Therapy start date: (b)(6) 2018.Therapy end date: (b)(6) 2018.

• Brand Name: EXACTAMIX 2 L EVA CONTAINER
• Type of Device: EXACTAMIX 2 L EVA CONTAINER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 7285778
• MDR Text Key: 100696006
• Report Number: MW5075392
• 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: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2020
• Device Lot Number: 60098865
• 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