MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 1000 ML EVA BAG; SET, I.V. FLUID TRANSFER

Lot Number 60248723

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2020

Event Type  malfunction  

Event Description

A 1000 ml eva bag with an inorganic, translucent floater.Observed by pharmacist prior to dispensing.Did not reach patient.

• Brand Name: 1000 ML EVA BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 11100411
• MDR Text Key: 224811559
• Report Number: MW5098585
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2023
• Device Lot Number: 60248723
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1