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

Model Number	7N8390
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified quantity of one-link non-dehp microbore catheter extension sets leaked at the connection to peripheral intravenous (piv) catheters.This was observed during patient use.On occasion when taking down the dressing, a loose connection was observed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B3/d10: the event occurred over the last few weeks before reporting the issue on november 24, 2025.D4: a suspect lot may be ur25f18055 which has a udi of (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d4 expiration date (update to n/a), h4, h6 (update codes), h11.H4: the suspect lot ur25f18055 has a manufacturing date of 06/26/2025.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of the suspect lot.The devices were not received for evaluation; therefore, a device analysis could not be completed.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 CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23858744
• Report Number: 1416980-2025-06174
• Device Sequence Number: 21429799
• Product Code: FPA
• UDI-Device Identifier: 00085412475417
• UDI-Public: (01)00085412475417
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: Health Professional
• Device Model Number: 7N8390
• Device Catalogue Number: 7N8390
• Device Lot Number: ASKU
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/20/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: PIV
• Patient Sex: Unknown