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

Model Number	H938176
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	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported eight exactamix inlets had ¿movable and immovable black particles inside the packaging.¿ the particulate was observed prior to patient use; therefore, there was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to g4, h6, h7, h9 and h11.Correction to h4: the lot was manufactured february, 2024.H11: the actual devices were not available; however, three (3) photographs of samples were provided for evaluation.Visual inspection was performed which identified two (2) photos with a dark particle embedded in the outside of the tubing, not in the fluid pathway.One (1) photo did not show any particulate matter.The reported condition was verified in two photos and not verified in one photo.The cause of the condition was determined to be contamination during the manufacturing or packaging process.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 ; 2242702068
• MDR Report Key: 23985854
• Report Number: 1416980-2026-00091
• Device Sequence Number: 10704040
• Product Code: LHI
• UDI-Device Identifier: 00085412475813
• UDI-Public: (01)00085412475813(10)803721(17)270208
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: H938176
• Device Catalogue Number: H938176
• Device Lot Number: 803721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002710954-08/09/24-001-
• Patient Sequence Number: 1
• Patient Sex: Unknown