MAUDE Adverse Event Report: CAREFUSION SMARTSITE VIALSHIELD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MV0520
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Chemical Exposure (2570)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer declined to return the product for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the vialshield spike cores stopper pieces of brand wg critical care paclitaxel into the drug vial while preparing in their pharmacy 50% of the time.There was no patient involvement.

• Brand Name: SMARTSITE VIALSHIELD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8746067
• Report Number: 9616066-2019-01761
• Device Sequence Number: 1488712
• Product Code: LHI
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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: MV0520
• Device Catalogue Number: MV0520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1