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

Model Number	H938751
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	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that particulate matter contamination was observed in seven (7) exactamix vented, micro-volume inlets.Two inlets had contamination that was described as, ¿spot on white connector and white part¿, two inlets had contamination that was described as, ¿spot on white connector¿, and three inlets had contaminated that was described as, ¿spot on white connector, white part and inside cap¿.This was found before 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.H4: the lot was manufactured between may 08, 2023 and may 09, 2023.H11: seven (7) actual devices and seven (7) photographs of the samples were provided for evaluation.The returned photographs were reviewed, and it was noted that there were small dark spots or particle(s) of foreign matter on the white valve connector and the spike housing of the products.The actual returned samples were visually inspected and it was noted that sample #1 had a dark particulate on the spike housing, sample #2 had a dark spot particulate on the white connector, sample #3 had a dark spot particulate on the white connector, sample #4 had a dark particulate on the spike housing, sample #5 had a dark particulate on the spike, sample #6 had a black spot on the white connector, and sample #7 had a dark spot particulate on the tubing.The reported condition was verified.The cause was determined to be related to manufacturing assembly and/or packaging process of supplier.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: 20429779
• Report Number: 1416980-2024-05682
• Device Sequence Number: 15350816
• Product Code: LHI
• UDI-Device Identifier: 00085412477299
• UDI-Public: (01)00085412477299(10)60461126(17)260430
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K903159
• 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): 02/06/2025

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: 04/30/2026
• Device Model Number: H938751
• Device Catalogue Number: H938751
• Device Lot Number: 60461126
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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