MAUDE Adverse Event Report: YUKON MEDICAL, LLC ARISURE 20 MM CLOSED VIAL ADAPTER; SET, I.V. FLUID TRANSFER

Model Number YM051

Device Problems Contamination (1120); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2019

Event Type  malfunction  

Event Description

The closed vial adapter pushed the metal stopper into the drug vial, causing leakage and contamination.Fda safety report id # (b)(4).

• Brand Name: ARISURE 20 MM CLOSED VIAL ADAPTER
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): YUKON MEDICAL, LLC; durham NC
• MDR Report Key: 8893640
• MDR Text Key: 154536011
• Report Number: MW5089016
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: YM051
• Device Catalogue Number: YM051
• Device Lot Number: 8235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1