MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXACTMIX 3L EVA CONTAINER

Lot Number 1214792

Device Problem Hole In Material (1293)

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

Event Date 06/26/2017

Event Type  malfunction  

Event Description

Small pin-sized hole along the seam on the top right corner of the exactmix 3000ml eva container.

• Brand Name: EXACTMIX 3L EVA CONTAINER
• Type of Device: EXACTMIX 3L EVA CONTAINER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 6672989
• MDR Text Key: 78701035
• Report Number: MW5070663
• 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: 06/26/2017

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 Expiration Date: 01/31/2020
• Device Lot Number: 1214792
• Other Device ID Number: REF: H938741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1