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

Catalog Number	2C8634
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).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 was leaking from the connector when attached to the intravenous (iv) hub.It was further reported that the leak continued as the nurse tried to tighten the connection at the hub.This was noted during patient use.The set was removed to continue therapy.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.A visual inspection was performed to the photograph using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.Due to the nature of the returned sample no additional testing could be performed.Therefore, the reported problem could not be verified or refuted.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 LUER ACTIVATED VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9990646
• Report Number: 1416980-2020-02323
• Device Sequence Number: 4355771
• Product Code: FPA
• UDI-Device Identifier: 00085412049021
• UDI-Public: (01)00085412049021
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 2C8634
• Device Lot Number: R19L05061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IV HUB, MAIN IV LINE