MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER MINIBAG PLUS; EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED

Lot Number 00338055318

Device Problem Device Reprocessing Problem (1091)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2021

Event Type  malfunction  

Event Description

Minibag plus iv bags with markings on the housing system.These look like they have burnt areas on them.These are multiple lot numbers and concern is for compromised sterility.Fda safety report id# (b)(4).

• Brand Name: BAXTER MINIBAG PLUS
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 11737819
• MDR Text Key: 248072064
• Report Number: MW5101039
• Device Sequence Number: 1
• Product Code: LXG
• 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: 04/26/2021

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 Lot Number: 00338055318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other