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

Model Number	7N8300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2026
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 a non-dehp microbore catheter extension set leaked where between the soft tubing and the hard connector (female luer lock) where the "microclave" (one-link) is attached.This was observed during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Correction to b5: update the device quantity to "two (02)".Additional information: d4: expiration date (update the null value to n/a), d9, g1: (device manufacturer name, address, city, state, country, country code, postal code), h3, h4, h6 (update codes), h11.H11: two (02) actual devices, two (02) photos and one companion sample were received for evaluation.Visual inspection of the returned photographs showed a drop of an unknown solution visible between the assembly of the microbore winged female luer lock adapter and the high pressure tubing; however, no separation was identified.Visual inspection of the returned devices and the companion sample did not identify any abnormalities that could have contributed to the reported condition.Pressure test, clear passage test, and pull test were performed.The pressure test failed for the actual devices, with continuous bubbles observed during the test period at the interface between the microbore winged female luer lock adapter and the high pressure tubing.The companion sample passed the pressure test.The reported condition was verified in the actual samples.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.

• Brand Name: ONE-LINK
• 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; ni; aibonito 00705 ; * 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24584463
• Report Number: 1416980-2026-00942
• Device Sequence Number: 9233895
• Product Code: FPA
• UDI-Device Identifier: 00085412091839
• UDI-Public: (01)00085412091839(10)UR25H06093
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 7N8300
• Device Catalogue Number: 7N8300
• Device Lot Number: UR25H06093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID.
• Patient Sex: Unknown