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

Catalog Number 2R8403

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2022

Event Type  malfunction  

Manufacturer Narrative

The user facility submitted medwatch (b)(4) for this event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system non-dehp solution set leaked from the distal y-site connection.The issue was identified during patient infusion with an unspecified chemotherapy drug.A drop of the chemotherapy drug got on patient's hand; however, the patient was instructed to wash their hands thoroughly.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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 not received for evaluation; 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
• Type of Device: 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 60073 ; 2242702068
• MDR Report Key: 15846708
• MDR Text Key: 307279402
• Report Number: 1416980-2022-06408
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412656649
• UDI-Public: (01)00085412656649
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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
• Device Operator: Other
• Device Catalogue Number: 2R8403
• Device Lot Number: DR22E23024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/21/2022
• Date Device Manufactured: 05/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CHEMOTHERAPY
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White