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

Model Number	2B8071
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vial-mate adapter leaked at the vial interface.The device was used to connect the vancomycin vial to the normal saline intravenous fluid bag.This occurred during patient infusion at the emergency department.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B3: event date and d10: concomitant product (1): therapy date^: the event occurred in an unspecified date of november, 2024.E1: initial reporter phone no.: (b)(6).(additional number) should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h4, h6, h11.H4: the lot was manufactured between september 5th ¿ 10th 2024.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VIAL-MATE
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north; po box 1058; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21073158
• Report Number: 1416980-2025-00003
• Device Sequence Number: 8444310
• Product Code: LHI
• UDI-Device Identifier: 00085412027388
• UDI-Public: (01)00085412027388(10)GR24H21017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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
• Operator of Device: Health Professional
• Device Model Number: 2B8071
• Device Catalogue Number: 2B8071
• Device Lot Number: GR24H21017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORMAL SALINE IV BAG.; VANCOMYCIN VIAL.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White