MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2C5645
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the packaging of an extension set was stained.This was observed 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: d4: expiration date (update the null value to n/a), h4, h6 (update codes), h11.H11: the actual device was not available; however, photographs of the sample were provided for evaluation.A visual inspection of the photographs observed stained packaging.The reported condition was verified.The cause of the condition could not be determined.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.
Additional Manufacturer Narrative
Additional information: h6(update codes), h11.H11: the cause of the issue was due to improper segregation of the material during manufacturing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NA
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; parque industrial de cartago; apartado no. 1-7052; cartago ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23611642
• Report Number: 1416980-2025-05785
• Device Sequence Number: 9917890
• Product Code: FPA
• UDI-Device Identifier: 00085412001814
• UDI-Public: (01)00085412001814(10)R25I26079
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K142011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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: 2C5645
• Device Catalogue Number: 2C5645
• Device Lot Number: R25I26079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 02/16/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/19/2025; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• 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