MAUDE Adverse Event Report: CAREFUSION SMARTSITE VIALSHIELD 20MM CLOSED VAD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MV0520
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that smartsite vialshield 20mm closed vad leaked.The following information was provided by the initial reporter: material no: mv0520 batch(lot) no: unknown- customer reported lot # is (10)9294 it was reported that adaptor leaked from an unknown location.Technician was drawing up fluorouracil using a 20 mm vial adaptor (mv0520) and drug started leaking from the vial adaptor at an undetermined location.
Additional Manufacturer Narrative
Due to no photo or sample being received, the customer's complaint of leakage could not be verified.A device history record review could not be performed because a correct lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that smartsite vialshield 20mm closed vad leaked.The following information was provided by the initial reporter: material no: mv0520 batch(lot) no: unknown- customer reported lot # is (10)9294 it was reported that adaptor leaked from an unknown location.Technician was drawing up fluorouracil using a 20 mm vial adaptor (mv0520) and drug started leaking from the vial adaptor at an undetermined location.

• Brand Name: SMARTSITE VIALSHIELD 20MM CLOSED VAD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10273763
• Report Number: 9616066-2020-02148
• Device Sequence Number: 11605828
• Product Code: FPA
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K132863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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: (10)9294
• 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: 07/14/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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: 20200623; 20200623
• Outcome Attributed to Adverse Event: Other