MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. VIAL-MATE; SET, I.V. FLUID TRANSFER

Model Number	2B8071
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Pt ordered for 3g ampicillin sulbactam to be reconstituted using vial to bag adapter.After hanging the medication, noted the drug was leaking from around the adapter and down the glass vial.

• Brand Name: VIAL-MATE
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 20189170
• Report Number: 20189170
• Device Sequence Number: 8069989
• Product Code: LHI
• UDI-Device Identifier: 00085412027388
• UDI-Public: (01)00085412027388
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/24/2024
• Report Date (Section F): 04/24/2024

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 Model Number: 2B8071
• Device Catalogue Number: 2B8071
• Device Lot Number: 2311164US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/24/2024