MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2N8341
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unspecified quantity of clearlink system non-dehp three lead extension sets leaked from one of the ports (luer connector) when connected; a disconnection was noted.This occurred during patient use.Non-baxter sets were used to resolve the event.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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 INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19639307
• Report Number: 1416980-2024-03299
• Device Sequence Number: 15587189
• Product Code: FPA
• UDI-Device Identifier: 00085412071657
• UDI-Public: (01)00085412071657
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 2N8341
• Device Catalogue Number: 2N8341
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown