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

Model Number	7N8391
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique device identifier (udi) # is based on the di information as no lot number was provided by the reporter.H11: the devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that unspecified units of one-link non-dehp standard bore catheter extension sets had air in line while in use with clearlink system non-dehp extension sets.This occurred during unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Correction to d10 (add product) and b5.B5: update to "it was reported that an unspecified quantity of one link non dehp standard bore catheter extension sets had air in line while being used with clearlink system non dehp extension sets (filter).The issue was described as, the filter was primed using an unspecified syringe, and after priming, a one link needle free iv connector was attached to the proximal end just above the filter so the assembly could be accessed similarly to a saline well or heparin lock".

• 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; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24324438
• Report Number: 1416980-2026-00557
• Device Sequence Number: 15964935
• Product Code: FPA
• UDI-Device Identifier: 00085412475400
• UDI-Public: (01)00085412475400
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 02/13/2026

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: 7N8391
• Device Catalogue Number: 7N8391
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 02/13/2026
• 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: CLEARLINK SYSTEM NON-DEHP EXTENSION SET; HEPARIN LOCK; ONE-LINK NEEDLE-FREE IV CONNECTOR; SALINE WELL; SYRINGE
• Patient Sex: Unknown