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

Model Number	2B8071
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that fluid was leaking back into the vials during use of an unspecified quantity of vial-mate adapters.This occurred during preparation once the vial activation was completed; the adapters were connected to sodium chloride bags and vancomycin vials.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.H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph did not show the reported defects.The reported condition was not verified on the photo sample.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: 20035881
• Report Number: 1416980-2024-04409
• Device Sequence Number: 19595113
• Product Code: LHI
• UDI-Device Identifier: 00085412027388
• UDI-Public: (01)00085412027388(10)GR24D04017
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/17/2024
• 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