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

Model Number	2C5641
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address - (b)(6).E1: initial reporter city - should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an extension set was leaking from the luer lock.This issue was observed while connected to a bag of blood/human cells prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: h11: the actual device was not available; however, photographs of the sample were provided for evaluation.The returned photographs were reviewed, and it was noted that the paper below the unit was wet in the area of the vented luer lock cap threaded onto the winged female luer lock adapter which suggested a leak had occurred; however, the leak and its source were not clearly visible.The reported condition was verified.The cause of the reported 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.

• Brand Name: EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd. 721, km. 0.3; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22772399
• Report Number: 1416980-2025-04119
• Device Sequence Number: 9487970
• Product Code: FPA
• UDI-Device Identifier: 00085412003818
• UDI-Public: (01)00085412003818(10)DR23H01024(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 09/11/2025

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 Model Number: 2C5641
• Device Catalogue Number: 2C5641
• Device Lot Number: DR23H01024
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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