MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 2000 ML EVA BAG; SET, I.V. FLUID TRANSFER

Lot Number 60245403

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2020

Event Type  malfunction  

Event Description

A 2000 ml eva bag leaking from central port.

• Brand Name: 2000 ML EVA BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 11100420
• MDR Text Key: 224811614
• Report Number: MW5098587
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2023
• Device Lot Number: 60245403
• 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