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

Model Number	2R8546
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
I was reported that the tubing disconnected at the y-port (clearlink) of a clearlink system, non-dehp continu-flo solution set during priming.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h4, h6, h11.H11: the device was received for evaluation.Visual inspection was performed which showed a separation between the tubing and the second y-site clearlink.It was also observed during visual inspection that there was a lack of solvent at the tubing (the solvent was not applied in all the circumference of the tubing).Dimensional testing was performed at the tubing and clearlink y-site housing and was according to specification.The reported condition was verified.The cause of the condition was a manufacturing issue.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; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21642368
• Report Number: 1416980-2025-01274
• Device Sequence Number: 18033537
• Product Code: FPA
• UDI-Device Identifier: 00085412565699
• UDI-Public: (01)00085412565699(10)R23J03055(17)251005
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: Other
• Device Expiration Date: 10/05/2025
• Device Model Number: 2R8546
• Device Catalogue Number: 2R8546
• Device Lot Number: R23J03055
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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: NI.
• Patient Sex: Unknown