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

Model Number	2C8864
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of clearlink system buretrol solution sets had the filter valve separate from the drip chamber; air leaked into the chamber.This was observed during priming.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B5: replace "there was no report of patient injury or medical intervention associated with this event." with "there was no patient involvement." h11: one (1) actual device and one (1) companion sample were received for evaluation.Visual inspection of the companion sample did not identify any abnormalities that could have contributed to the reported condition.Pressure and pull tests were performed on the companion sample, and no leaks or separation were observed.A visual inspection using the naked eye was performed on the actual sample, and a separation between the tubing and check valve was observed.Pressure and clear passage testing were performed on the actual sample, and a leak was noted in the set, however, no blockage was observed.A pull test was performed on the actual sample, and no separation was observed in other joints of the set.The reported leak was verified on the actual sample; however not verified on the companion sample.The cause of the leak is due the assembly process during manufacturing.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: 19460694
• Report Number: 1416980-2024-02716
• Device Sequence Number: 6652549
• 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: Non-Healthcare Professional
• 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?: Device Returned to Manufacturer
• 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: 06/04/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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