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

Model Number	2B8071
Medical Device Problem Codes	Backflow (1064); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was unrestricted fluid flow through four (4) vial-mate adapters.The vial-mates were connected to the fluid bag, and fluid was being squeezed into the vial.However, the fluid was found to be regurgitating up and out of the top of the vial-mates.Similarly, when hung on the hook, the fluid backflowed and came out of the top of the vial-mate.This was observed during setup prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: the lot was manufactured between april 30, 2024 and may 07, 2024.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 INTERNATIONAL INC.; 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: 20515205
• Report Number: 1416980-2024-06013
• Device Sequence Number: 13069440
• Product Code: LHI
• UDI-Device Identifier: 00085412027388
• UDI-Public: (01)00085412027388(10)GR24D04017
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: 2B8071
• Device Catalogue Number: 2B8071
• Device Lot Number: GR24D04017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/23/2024
• 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
• Patient Sex: Unknown