MAUDE Adverse Event Report: CAREFUSION SMARTSITE VIALSHIELD CLOSED VIAL ACCESS DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MV0520
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics were not provided.
Event or Problem Description
It was reported that tubing leaked.During prepping in the pharmacy, the pharmacist was priming the bag and noticed the tubing was leaking near the closed vial access device.This happened twice.There was no patient involvement.
Event or Problem Description
It was reported the closed vial access device (cvad) has a leaking issue.The issue was noted while the pharmacist was preparing an unspecified hazardous medication.The issue occurred twice on (b)(6) 2020.There was no patient involvement as the event occurred in the pharmacy department.

• Brand Name: SMARTSITE VIALSHIELD CLOSED VIAL ACCESS DEVICE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9728001
• Report Number: 9616066-2020-00501
• Device Sequence Number: 19367962
• Product Code: FPA
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K132863
• 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): 01/30/2020

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: 10/28/2022
• Device Model Number: MV0520
• Device Catalogue Number: MV0520
• Device Lot Number: 9240
• 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: 02/19/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1