MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2R8519
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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 the tubing of a non-dehp continu-flo solution set got separated at the y-site.The device contained saline.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h4, h6, and h11: h4: the lot was manufactured between march 21, 2025 ¿ march 22, 2025.H11: the device was received for evaluation.A visual inspection was performed, and the tubing separated from the first y-site clearlink at the downstream part was observed.There was a lack of solvent that was not applied in all the circumference of the tubing.The insertion of the tubing into the first y-site clearlink was not according to specifications.The reported condition was verified.The cause was determined to be from improper manual assembly.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: CLEARLINK/CONTINU-FLO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; parque industrial de cartago; apartado no. 1-7052; cartago ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23063236
• Report Number: 1416980-2025-04621
• Device Sequence Number: 10044122
• Product Code: FPA
• UDI-Device Identifier: 00085412565682
• UDI-Public: (01)00085412565682(10)R25C21024(17)270321
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180739
• 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,Followup
• Report Date (Section B): 10/17/2025

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: 2R8519
• Device Catalogue Number: 2R8519
• Device Lot Number: R25C21024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: NORMAL SALINE
• Patient Sex: Unknown