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

Model Number	2C8851
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clearlink system nitroglycerin set leaked from unspecified location.This occurred while priming with normal saline.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to d4 expiration date (update to n/a), h4, h6, and h11: h11: the actual device was not available; however, a photograph and video of the sample were provided for evaluation.A visual inspection was performed on the photo and video sample, and the reported leak was observed.The reported condition was verified.The cause of the condition could not be determined.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/DUO-VENT
• 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: 21548509
• Report Number: 1416980-2025-01013
• Device Sequence Number: 19994365
• Product Code: FPA
• UDI-Device Identifier: 00085412046365
• UDI-Public: (01)00085412046365(10)R24G23161
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 2C8851
• Device Catalogue Number: 2C8851
• Device Lot Number: R24G23161
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• 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
• Patient Sex: Unknown