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

Model Number	MV0520
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that while detaching a syringe from a fluorouracil vial, the "blue part" originally attached to the spike "fell off." it was reported that this caused a delay in the preparation process and created a spill and vapors coming from the fluorouracil vial.There was no patient involvement and no harm to the user.
Additional Manufacturer Narrative
Additional information added to: d4, h.4, and h.6.(device codes).The customer complaint of while detaching a syringe from a fluorouracil vial, the "blue part" originally attached to the spike fell off was confirmed.Photo provided by the customer observed that the smartsite valve port that is attached to the top cap of the vial shield was broken off.The root cause of this failure was not identified as no product was returned.
Event or Problem Description
It was reported that while detaching a syringe from a fluorouracil vial, the "blue part" originally attached to the spike "fell off." it was reported that this caused a delay in the preparation process and created a spill and vapors coming from the fluorouracil vial.It was confirmed that there was no patient involvement and no harm to the user.

• 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: 9318406
• Report Number: 9616066-2019-03266
• Device Sequence Number: 606765
• 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: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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
• Device Lot Number: 9203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYRINGE, THERAPY DATE: (B)(6) 2019.