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

Model Number	2C8864
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: the event occurred during last few weeks from receiving the complaint on may 9, 2024.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of three (3) clearlink system buretrol solution sets completely separated during priming.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H11: the actual device was not available; however, one hundred (100) companion samples were evaluated.The sets were visually inspected, and a separation was observed between the tubing and check valve in five (5) of the units.The sets underwent functional push-pull, underwater leak, and clear passage testing and a leak occurred in five sets and no blockages were noted in any of the devices.The reported condition was verified on the companion samples.The cause of the condition could not be determined; however, the most probable cause was due to a manufacturing issue.A nonconformance has been opened to address this issue.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/BURETROL
• 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: 19452721
• Report Number: 1416980-2024-02684
• Device Sequence Number: 8545574
• Product Code: FPA
• UDI-Device Identifier: 00085412071121
• UDI-Public: (01)00085412071121(10)DR23I01062
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 2C8864
• Device Catalogue Number: 2C8864
• Device Lot Number: DR23I01062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2023
• 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