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

Model Number	H938175
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
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 ninety three (93) vented micro-volume inlets had particulate inside the packaging.This was observed during inspection.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h4, h6(update codes), h11.H4: the lot was manufactured in september 2025.H11: forty-two (42) unused devices were received for evaluation.Visual inspection of the returned samples showed particulate matter which was observed at the connector or tubing either inside the fluid path or outside the tubing.The issue was verified on the returned samples.The cause of the issue was due to supplier contamination related to manufacturing.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: EXACTAMIX
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ECM - PLASTICOS Y MATERIAS PRIMAS PYMPSA- SP013600; 3609-2 juan de la barrera; parque industrial el alamo; guadalajara, jalisco 44490 ; MX 44490
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24889452
• Report Number: 1416980-2026-01324
• Device Sequence Number: 21288059
• Product Code: LHI
• UDI-Device Identifier: 00085412475806
• UDI-Public: (01)00085412475806(10)804060(17)280821
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K002705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: Other
• Device Model Number: H938175
• Device Catalogue Number: H938175
• Device Lot Number: 804060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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