MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER 1000ML EXACTAMIX EVA; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Lot Number N22-0440

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

Event Date 03/24/2024

Event Type  malfunction  

Event Description

Baxter exactamix em 1000ml ethylene-vinyl acetate bag found to have small plastic article floating inside bag.

• Brand Name: BAXTER 1000ML EXACTAMIX EVA
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 19003760
• MDR Text Key: 339064068
• Report Number: MW5153357
• 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: 03/26/2024

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 Lot Number: N22-0440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose