MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX; SYSTEM/DEVICE, PHARMACY COMPOUNDING

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)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction

• Brand Name: EXACTAMIX
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• 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 NA 44490 ; MX 44490
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50236746
• Report Number: 1416980-2026-02633
• Device Sequence Number: 10373912
• Product Code: NEP
• UDI-Device Identifier: 00085412475790
• UDI-Public: (01)00085412475790(17)281028(10)804108
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• PMA/510(K) Number: K002705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: Health Professional
• Device Model Number: H938174
• Device Catalogue Number: H938174
• Device Lot Number: 804108
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown