MAUDE Adverse Event Report: BD / CAREFUSION / YUKON MEDICAL, LLC 20MM SMARTSITE VENTED VIAL ACCESS DEVICE; I.V, FLUID TRANSFER SET

Model Number	MV0420
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple vials of bendeka brand of bendamustine 100 mg vial have rubber vial stoppers that are too thick and resistant to puncture by ctsd (closed system transfer devices) now required by usp 800.The stoppers can dislodge and be forced into the vials, risking employee exposure to niosh listed hazardous medications and risking pyrogenic particle contamination of medications reaching pts.Fda safety report id# (b)(4).

• Brand Name: 20MM SMARTSITE VENTED VIAL ACCESS DEVICE
• Common Device Name: I.V, FLUID TRANSFER SET
• Manufacturer (Section D): BD / CAREFUSION / YUKON MEDICAL, LLC ; durham NC 27703
• MDR Report Key: 9397231
• Report Number: MW5091379
• Device Sequence Number: 19576598
• Product Code: LHI
• UDI-Device Identifier: 10885403228452
• UDI-Public: (01)10885403228452
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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): 11/27/2019

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 Model Number: MV0420
• Device Catalogue Number: MV0420
• Device Lot Number: (10) 9233
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1