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

Model Number MV0420

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Protective Measures Problem (3015)

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

Event Date 11/26/2019

Event Type  malfunction  

Event 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
• Type of Device: I.V, FLUID TRANSFER SET
• Manufacturer (Section D): BD / CAREFUSION / YUKON MEDICAL, LLC ; durham NC 27703
• MDR Report Key: 9397231
• MDR Text Key: 168787917
• Report Number: MW5091379
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10885403228452
• UDI-Public: (01)10885403228452
• Combination Product (y/n): Y
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV0420
• Device Catalogue Number: MV0420
• Device Lot Number: (10) 9233
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1