MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK; SET, BLOOD TRANSFUSION

Model Number	2C8750
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was ambulating in hall; rn noticed a line dragging on the floor.Patients' blood tubing that was infusing platelets had broken away from luer connector that was connected to the patients picc [peripherally inserted central catheter] line.No harm to patient.

• Brand Name: CLEARLINK
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 24245945
• Report Number: 24245945
• Device Sequence Number: 15531078
• Product Code: BRZ
• UDI-Device Identifier: 00085412046341
• UDI-Public: (01)00085412046341
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/21/2026
• Report Date (Section F): 01/21/2026

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
• Device Model Number: 2C8750
• Device Catalogue Number: 2C8750
• Device Lot Number: (10) DR25A13048
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/21/2026