MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2H8671
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date ¿ this event occurred on an unspecified date in june 2025.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the filter of a clearlink non-dehp extension set had a broken membrane.This issue was discovered during setup/preparation prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h4 and h6.The actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was noted that the membrane of the filter was damaged.The reported condition was verified.The cause of the damaged component was a manufacturing issue (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
• 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: 22908238
• Report Number: 1416980-2025-04387
• Device Sequence Number: 9089549
• Product Code: FPA
• UDI-Device Identifier: 00085412080956
• UDI-Public: (01)00085412080956(10)R24K23093(17)291125
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K153158
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: 2H8671
• Device Catalogue Number: 2H8671
• Device Lot Number: R24K23093
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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: NA.
• Patient Sex: Unknown