MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXACTAMIX 2 L EVA CONTAINER; SET, I.V, FLUID, TRANSFER

Lot Number 60119792

Device Problem Material Puncture/Hole (1504)

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

Event Date 11/03/2018

Event Type  malfunction  

Event Description

There is a hole in the middle of the exactamix 2 l eva container.This was discovered before any pt contact.Dates of use: (b)(6) 2018.Is the product compounded? no; is the product over-the-counter? no.

• Brand Name: EXACTAMIX 2 L EVA CONTAINER
• Type of Device: SET, I.V, FLUID, TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 8160481
• MDR Text Key: 130467378
• Report Number: MW5082082
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 60119792
• 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