MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2R8403
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a clearlink system non-dehp solution set leaked from an unspecified location.Additionally, the event occurred after the set had been primed with saline.The set was sent to the unit; however, the leak was observed prior to patient contact.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
B5: upon additional information, the leak was observed "at the drip chamber".H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK LUER ACTIVATED VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 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 ; 2242702068
• MDR Report Key: 15714774
• Report Number: 1416980-2022-05967
• Device Sequence Number: 15117621
• Product Code: FPA
• UDI-Device Identifier: 00085412656649
• UDI-Public: (01)00085412656649
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2022

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 2R8403
• Device Lot Number: DR21I08031
• 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: 10/05/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 12/02/2022
• Date Device Manufactured: 09/09/2021
• 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