MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP EXACTAMIX 250 ML EVA CONTAINER BAG

Catalog Number H938737

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 around the middle of the exactamix 250 ml eva container.(the area around the suspected location of the hole is circled on the product).Therapy date: (b)(6) 2018.

• Brand Name: EXACTAMIX 250 ML EVA CONTAINER BAG
• Type of Device: EXACTAMIX 250 ML EVA CONTAINER BAG
• Manufacturer (Section D): BAXTER HEALTHCARE CORP
• MDR Report Key: 7273306
• MDR Text Key: 100297449
• Report Number: MW5075268
• 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: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: H938737
• Device Lot Number: 60095447
• 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