MAUDE Adverse Event Report: CAREFUSION SMARTSITE 20MM CLOSED VIAL ACCESS DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MV0520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.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 the injection port broke off of the adaptor when attempting to drawn medication out of the vial.There was no patient involvement.
Event or Problem Description
It was reported that the injection port broke off of the adaptor when attempting to drawn medication out of the vial.It was further confirmed during follow up, that there was no patient involvement associated with this event, and subsequently, no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
"3rd party manufacturing date provided as 10/2019".Additional information added; section; b.5.(patient information clarified/detailed), and h.6.(patient code).The customer complaint of injection port broke off was confirmed.A photo provided by the customer shows that the smartsite port was broken off from the top of the smartste vial shield access device.The root cause of this failure was not identified as no product was returned.

• Brand Name: SMARTSITE 20MM CLOSED VIAL ACCESS DEVICE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9631864
• Report Number: 9616066-2020-00285
• Device Sequence Number: 16844137
• Product Code: FPA
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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,Followup
• Report Date (Section B): 01/10/2020

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 Expiration Date: 10/28/2022
• Device Model Number: MV0520
• Device Catalogue Number: MV0520
• Device Lot Number: 9242
• 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: 01/27/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1