MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXACTAMIX 2L EVA CONTAINER; SYSTEM/ DEVICE, PHARMACY, COMPOUNDING

Lot Number 60101121

Device Problem Hole In Material (1293)

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

Event Date 02/09/2018

Event Type  malfunction  

Event Description

There is a pin-sized hole (circled on the bag) on the 2l exactamix eva container.

• Brand Name: EXACTAMIX 2L EVA CONTAINER
• Type of Device: SYSTEM/ DEVICE, PHARMACY, COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 7365921
• MDR Text Key: 103362203
• Report Number: MW5076045
• 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: 03/19/2018

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: 11/01/2020
• Device Lot Number: 60101121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1