MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINI-BAG PLUS CONTAINER; EQUIPMENT, LABORATORY, GENERAL PURPOSE

Lot Number P385831

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 01/16/2019

Event Type  malfunction  

Event Description

A baxter mini bag plus 100ml container was found to have significantly less fluid than 100ml, approx half the volume.The bag appeared completely dry, and there did not seem to be any leaks or breaks in the bag.However, upon closer inspection, when the bag was squeezed, drops of fluid leaked from the junction between the bag and the blue vial adapter piece.Strength: 100 ml millilitre(s).Therapy start date: (b)(6) 2019.

• Brand Name: MINI-BAG PLUS CONTAINER
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 8266913
• MDR Text Key: 134019010
• Report Number: MW5083257
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 00338055318
• UDI-Public: 00338-0553-18
• 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: 01/17/2019

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: 10/31/2019
• Device Lot Number: P385831
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1