MAUDE Adverse Event Report: YUKON MEDICAL, LLC SMARTSITE UNIVERSAL VENTED VIAL ACCESS DEVICE

Model Number MV0400-0006

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

Final comments from the manufacturer since corrective actions were implemented in association with a corrective action (car-000036) initiated as a result of a rmi- (b)(4) opened for the lot reported by the end-user, no additional actions are intended at this time.

Event Description

Summary of event or problem: the customer reported that during withdrawal of chemo drug from the vial, a leakage occurred at the junction of the smartsite valve and the body of the device (green part where the /smartsite is glued).This issue occurred ten times in the same day, it occurred also with folic acid (levofolene).Note: yukon medical was originally made aware of this reported problem on (b)(4) 2016.It was originally assessed as an eu (european union) trend report only, but was later reassigned as an eu reportable event.A (b)(6) was submitted to the competent authority on 7mar2017.Yukon was unaware at the time that all eu events were required to be reported to the fda.As a result of an fda inspection completed at our site on 6apr2018, it was communicated by the investigator that eu events need to also be reported in the us if the device is marketed in the us.Therefore, yukon medical is reporting the event at this time.This is one of two events that is being reported.

• Brand Name: SMARTSITE UNIVERSAL VENTED VIAL ACCESS DEVICE
• Type of Device: SMARTSITE UNIVERSAL VENTED VIAL ACCESS DEVICE
• Manufacturer (Section D): YUKON MEDICAL, LLC; 4021 stirrup creek drive,; suite 200; durham NC 27703
• Manufacturer (Section G): YUKON MEDICAL,LLC; 4021 stirrup creek drive; suite 200; durham 27703
• Manufacturer Contact: pamela mcnulty ; 4021 stirrup creek drive,; suite 200; durham, NC 27703 ; 9195958253
• MDR Report Key: 7427169
• MDR Text Key: 105664947
• Report Number: 3009631669-2016-00004
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: K122265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/07/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: MV0400-0006
• Device Catalogue Number: MV0400-0006
• Device Lot Number: MV0400-0006 6215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1