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

Model Number	H938174
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
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 particulate matter contamination in twenty one (21) exactamix vented, high-volume inlets.The pm was described as ¿hairs, particles, and lint in the outer packaging, the inlet, and/or on the connectors¿.These issues were observed prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h4: the lot was manufactured in february 2025.H11: twenty one (21) actual devices were received for evaluation.Visual inspection of returned samples showed dark/brownish fiber, dark/yellow spots embedded on connectors, spike ports, or within packaging, all outside the tubing and not in the fluid pathway.The white liquid like material was observed inside the transparent cap of the white spike connector and within the fluid pathway.The reported condition was verified.The cause of the condition was possibly inherent to 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: 24048058
• Report Number: 1416980-2026-00174
• Device Sequence Number: 13135093
• Product Code: LHI
• UDI-Device Identifier: 00085412475790
• UDI-Public: (01)00085412475790(10)803933(17)280201
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: H938174
• Device Catalogue Number: H938174
• Device Lot Number: 803933
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 06/19/2026
• 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