MAUDE Adverse Event Report: CAREFUSION CAREFUSION 20MM SMARTSITE VIALSHIELD; SET, I.V. FLUID TRANSFER

Device Problems Break (1069); Material Separation (1562)

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

Event Type  malfunction  

Event Description

Carefusion vialshield 20 mm device is part of a closed system transfer device to be used in the preparation of chemotherapy in a pharmacy.The connections on the device are supposed to be sealed by glue and were separating once a syringe was attached.This occurred with 2 products and a 3rd one broke at the connection and lead to a small chemo spill.Staff was instructed to hold device at the connection to assume it wasn't sealed at manufacturer's product was intended.

• Brand Name: CAREFUSION 20MM SMARTSITE VIALSHIELD
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 10232772
• MDR Text Key: 197793925
• Report Number: MW5095354
• Device Sequence Number: 3
• 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: 07/01/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1