MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK 3 PORT ADAPTER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N8334
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 piece of the y-connector of a clearlink system non-dehp 3 port adapter broke off at the connection to the iv tubing causing a leak/inadequate delivery of medication.This occurred during a surgical procedure.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph observed that the triple connector was broken (a luer connector broke off the adapter).The reported condition was verified.The cause of the condition could not be determined; however, a probable cause is due to user handling of the device.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 3 PORT ADAPTER
• 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 60073 ; 2242702068
• MDR Report Key: 19064205
• Report Number: 1416980-2024-01577
• Device Sequence Number: 14956709
• Product Code: FPA
• UDI-Device Identifier: 00085412048505
• UDI-Public: (01)00085412048505
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K913627
• 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): 05/13/2024

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 Catalogue Number: 2N8334
• Device Lot Number: DR23G07062
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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: UNSPECIFIED MEDICATION
• Patient Sex: Unknown