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

Model Number	2H8671
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was receiving jemperli, needed a filter added to the line.When attaching the one-link needleless connector onto the filter, the one-link kept twisting on the filter, not luer-locking into place.If you twisted it on, you could just pull the one-link off of the filter.The luer-lock of the filter appears sharp and jagged.Writer used same one-link cap and twisted onto new filter with no issue, so writer knew this filter was faulty.(b)(4), lot (10) r25k130310.

• Brand Name: CLEARLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 24303845
• Report Number: 24303845
• Device Sequence Number: 5215063
• Product Code: FPA
• UDI-Device Identifier: 00085412080956
• UDI-Public: (01)00085412080956
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/02/2026
• Report Date (Section F): 02/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: 2H8671
• Device Catalogue Number: 2H8671
• Device Lot Number: R25K13031
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 02/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/02/2026