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

Model Number	7N8332K
Medical Device Problem Codes	Obstruction of Flow (2423); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 an unspecified quantity of one-link non-dehp 3 lead microbore catheter extension sets had air entering the lines; further described as "interrupted lines".This was observed during patient use in the neonatal intensive care unit (nicu).Additionally, the event was further described as devices not having "negative pressure" which resulted in the lines backing up; if the to keep open (tko) pressure was not high enough, there was clotting as well.The customer was working with staff to ensure proper tightening of the connection to the intravenous (iv) tubing.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21913662
• Report Number: 1416980-2025-02501
• Device Sequence Number: 17947089
• Product Code: FPA
• UDI-Device Identifier: 00085412599625
• UDI-Public: (01)00085412599625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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: Health Professional
• Device Model Number: 7N8332K
• Device Catalogue Number: 7N8332K
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/25/2025
• 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: IV TUBING
• Patient Sex: Unknown