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

Model Number	2C8634
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
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 a clearlink system extension set split (separated) in two pieces.This was observed during an apheresis procedure.The patient was accessed with a 16g non-baxter high-flow needle.At the end of the procedure, the nurse placed a non-baxter connector and flushed the line without issues.When the nurse returned to the room approximately 10 minutes later, the extension set split in two pieces, leaving the port open to air.The nurse immediately inserted the one end back into the other and aspirated any air that may have been in the line.The port needle was then removed per protocol.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H11: the actual device and a photograph was received for evaluation; however, the male luer was not returned.A visual inspection of the photo noted a separation between the tubing and male luer.A visual inspection of the actual device identified the tubing separated from the male luer (not returned).Further inspection revealed that solvent was applied uniformly.Dimensional testing was performed on the tubing with no issues noted.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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 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: 20260969
• Report Number: 1416980-2024-05119
• Device Sequence Number: 8695759
• Product Code: FPA
• UDI-Device Identifier: 00085412049021
• UDI-Public: (01)00085412049021(10)R23A24062
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: Health Professional
• Device Model Number: 2C8634
• Device Catalogue Number: 2C8634
• Device Lot Number: R23A24062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 16G HIGH-FLOW NEEDLE; PORT-A-CATH; Q-SYTE
• Patient Sex: Unknown