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
Date of event: unknown.The date received by manufacturer has been used for this field.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 no.: unknown.It was reported, that the vial adaptor leaks at an undetermined location.
Additional Manufacturer Narrative
While a video was received from the customer and a leak could be observed, the exact location of the leak could not be determined.Therefore, the complaint of leaking from the vial adaptor could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mv0520 because a valid 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 no: unknown.It was reported, that the vial adaptor leaks 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: 10267786
• Report Number: 9616066-2020-02074
• Device Sequence Number: 14184794
• 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: Other
• Device Model Number: MV0520
• Device Catalogue Number: MV0520
• Device Lot Number: UNKNOWN
• 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: 07/13/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other