MAUDE Adverse Event Report: BAXTER BAXTER VIALMATE

Lot Number GR15K04011

Device Problems Device Operates Differently Than Expected (2913); Packaging Problem (3007)

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

Event Date 03/07/2016

Event Type  malfunction  

Event Description

Baxter vialmate 1/2 box of lot gr15k04011 left cored vial stopper in vial after reconstitution of vial using product.Visually identified upon inspection.Multiple medication vials with multiple mfrs have caused this coring issue.

• Brand Name: BAXTER VIALMATE
• Type of Device: BAXTER VIALMATE
• Manufacturer (Section D): BAXTER
• MDR Report Key: 5671066
• MDR Text Key: 45768276
• Report Number: MW5062414
• Device Sequence Number: 1
• Product Code: LHI
• 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: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: GR15K04011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other