MAUDE Adverse Event Report: CAREFUSION SMARTSITE NEEDLE-FREE VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2000EA
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.
Event or Problem Description
The customer reported that when disconnecting a doxorubicin iv push, it leaked on the outside top of the valve.The customer states "this happens with every use" however no details were given for other specific events therefore, this is the only file.The leak could be with every chemotherapeutic drug but the doxorubicin is orange and can be seen.There was no patient harm.

• Brand Name: SMARTSITE NEEDLE-FREE VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7735906
• Report Number: 9616066-2018-01182
• Device Sequence Number: 19034080
• Product Code: FPA
• UDI-Device Identifier: 07613203012751
• UDI-Public: 7613203012751
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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 Expiration Date: 10/16/2020
• Device Model Number: 2000EA
• Device Catalogue Number: 2000EA
• Device Lot Number: 17106733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR