MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK BURETROL SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2H8865
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	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the luer valves of three (3) clearlink system non-dehp buretrol sets were "loose and not bonded" and subsequently the luer separated from the tubing.This was observed prior to use.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
One (1) actual sample was received for evaluation.The other samples were not received and therefore, could not be evaluated.Visual inspection was performed using the naked eye which observed that the luer activated valve was separated from the burette.The other components were correctly placed according to specifications.Dimensional testing was performed at the set and no defect was observed.Additionally, it was observed that the luer did not have solvent in the joint.The reported condition was verified.The cause of the condition was due to manufacturing process related.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 SOLUTION SETS
• 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: 15064672
• Report Number: 1416980-2022-03732
• Device Sequence Number: 5570382
• Product Code: FPA
• UDI-Device Identifier: 00085412071183
• UDI-Public: (01)00085412071183
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/22/2022

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: Health Professional
• Device Catalogue Number: 2H8865
• Device Lot Number: DR22A17055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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