MAUDE Adverse Event Report: YUKON MEDICAL LLC SMARTSITE; SMARTSITE VIALSHIELD MV0520

Catalog Number	MV0520
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Today we found one of our carefusion 20mm closed vial access device (mv0520 smartsite vialshield) with small pieces of gray or black particulate matter sealed between the flexible diaphragm and the hard white plastic reservoir.The particle might be able to enter the vial as it is being reconstituted.The lot number is 6238, and the expiration date of the product is 11/28/2019.

• Brand Name: SMARTSITE
• Common Device Name: SMARTSITE VIALSHIELD MV0520
• Manufacturer (Section D): YUKON MEDICAL LLC; durham NC 27703
• MDR Report Key: 6820526
• Report Number: MW5071787
• Device Sequence Number: 11058152
• Product Code: LHI
• UDI-Device Identifier: 10885403228117
• UDI-Public: (01)10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/22/2017

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: 11/28/2019
• Device Catalogue Number: MV0520
• Device Lot Number: 6238
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1