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

Model Number	H938792
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	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported particulate was observed on twelve (12) exactamix em1200 valve sets.There was loose white pm (particulate matter) covering the port caps.This occurred 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: d9, h3, h4, h6, h11.H11: six devices and five photographs of the sample were provided for evaluation.Visual inspection was performed on all the samples.The reported issue of contamination of foreign matter was observed in the photos with white particulates seen on the caps of the ports and dark spots observed on the caps of the ports of the products.Sample 1 had small white particulate on cap of port 8, sample 2 had dark tiny spots or on tubing, sample 3 had small white spot-on tubing, sample 4 had small white spots on tubing, and a tiny dark spot particulate on the cap of port 5, sample 5 had small white spot-on tubing, sample 6 had small tiny dark spot on cap of port 2, small white spot and tiny black spot on cap of port 6 and dark spots of particulate matter on or embedded in tubing.The reported condition was verified.The cause of the condition could not be determined; however, it was possibly a manufacturing issue.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): AVAILMED; c. industrial lt 001 mz 105; no 20905 int a, col cd ind; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20417438
• Report Number: 1416980-2024-05612
• Device Sequence Number: 12836005
• Product Code: LHI
• UDI-Device Identifier: 00085412477305
• UDI-Public: (01)00085412477305(10)60417696(17)250831
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K002705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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 Expiration Date: 08/31/2025
• Device Model Number: H938792
• Device Catalogue Number: H938792
• Device Lot Number: 60417696
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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