MAUDE Adverse Event Report: CAREFUSION NDLELESS VLV ADPT ARTERIAL; SET, ADMIN, INTRAVASCULAR.

Model Number	2000EA
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.
Event or Problem Description
It was reported that the needle free valve leaked at connection to the easypump.Although requested, additional information was not provided.
Event or Problem Description
It was reported that the needle free valve leaked at connection to the easypump.Although requested, additional information was not provided.
Additional Manufacturer Narrative
Additional information added to: d11.The customer¿s report that the needle free valve leaked at connection could not be confirmed.The two reported smartsite connectors model 2000ea with lots 19075407 and 20035881 that were in use during the customer event were not returned for evaluation.A device history record for model 2000ea with lot number 19075407 was performed.The search showed that a total of (b)(4) units were built in 1 lot on 06jul2019.The search showed that there were no quality notifications for the failure mode reported by the customer.A device history record for model 2000ea with lot number 20035881 was performed.The search showed that a total of (b)(4) units were built in 1 lot on 09mar2020.The search showed that there were no quality notifications for the failure mode reported by the customer.The root cause of this failure was not identified as no product was returned.

• Brand Name: NDLELESS VLV ADPT ARTERIAL
• Common Device Name: SET, ADMIN, INTRAVASCULAR.
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10017349
• Report Number: 9616066-2020-01447
• Device Sequence Number: 14278745
• Product Code: FPA
• UDI-Device Identifier: 07613203012751
• UDI-Public: 7613203012751
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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 Expiration Date: 07/06/2022
• Device Model Number: 2000EA
• Device Catalogue Number: 2000EA
• Device Lot Number: 19075407
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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: BBRAUN EASYPUMP,THERAPY DATE UNK