MAUDE Adverse Event Report: BAXTER EXACTMIX 3 L EVA CONTAINER; SYSTEM/DEVICE, PHARMACY

Model Number REF H938741

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 03/15/2017

Event Type  malfunction  

Event Description

There is a small pin-sized hole located on the bottom right corner of the exactmix 3 l eva container.

• Brand Name: EXACTMIX 3 L EVA CONTAINER
• Type of Device: SYSTEM/DEVICE, PHARMACY
• Manufacturer (Section D): BAXTER
• MDR Report Key: 6420346
• MDR Text Key: 70540440
• Report Number: MW5068554
• Device Sequence Number: 1
• Product Code: NEP
• 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: 03/17/2017

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 Model Number: REF H938741
• Device Catalogue Number: H938741
• Device Lot Number: 1159862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1