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

Lot Number 18L05G50

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2019

Event Type  malfunction  

Event Description

Minibag plus - baxter lot # 18l05g50, exp 08/2019, piperacillin/tazobactam 3.375 gram vial xgen lot # 1pu17102, exp 12/2019.Unable to dissolve powder and to get medication transferred to bag.Fda safety report id# (b)(4).

• Brand Name: MINIBAG PLUS
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 8731391
• MDR Text Key: 149261534
• Report Number: MW5087597
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 06/20/2019

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: 08/01/2019
• Device Lot Number: 18L05G50
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2019
• Patient Sequence Number: 1