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

Model Number	H938174
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 particulate matter was observed in the outer packaging, inlet, or connectors of eight (8) exactamix inlets.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h4, h6, and h11.H4: this lot was manufactured july 2025.H11: eight (8) unopened samples were received for evaluation.Visual inspection and inspection under magnification were performed and revealed various types of foreign matter enclosed in the sealed product packaging.Sample #1 0.2545 inch white liquid shape embedded in the transparent cap of white spike connector, inside the tubing, in the fluid pathway.Sample #2 0.02 mm dark spot embedded on the tubing, not in the fluid pathway.Sample #3 0.02 mm dark spot embedded on the tubing, not in the fluid pathway.Sample #4 0.02 mm imperfection spot embedded on the tubing, not in the fluid pathway.Sample #5 two 0.02 mm imperfection spots embedded on the tubing, not in the fluid pathway.Sample #6 0.1515 inch white liquid shape embedded in the transparent cap of white spike connector, inside the tubing, in the fluid pathway.Sample #7 0.0280 inch dark fiber embedded inside the tubing, in the fluid pathway.Sample #8 0.1855 inch white liquid shape embedded in the transparent cap of white spike connector, inside the tubing, in the fluid pathway.The reported condition was verified.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: 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 44490 ; MX 44490
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24905246
• Report Number: 1416980-2026-01350
• Device Sequence Number: 9067305
• Product Code: NEP
• UDI-Device Identifier: 00085412475790
• UDI-Public: (01)00085412475790(10)804038(17)280713
• 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): 07/01/2026

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: 804038
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 07/01/2026
• 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