MAUDE Adverse Event Report: CAREFUSION SMARTSITE BAG ACCESS DEVICE; SET, EXTENSION, INTRAVASCULAR

Model Number	2300E-0500
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
Event or Problem Description
It was reported from the operating room (or) that the bag access device clear male connector is coming off of the white barrel.A few anesthesia providers were potentially exposed to medications, including epinephrine, dopamine, and milrinone.This would be skin exposure, no mucous membrane exposure reported.The customer further stated given the nature of their use of the product , no patient exposure is expected.Delays in patient treatment possible, as provider would need to find alternative equipment for drawing up medication from the bag.Also potential provider exposure to medications when the bag contents leaks out.There was no harm to patient on this particular failure.

• Brand Name: SMARTSITE BAG ACCESS DEVICE
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9631860
• Report Number: 9616066-2020-00276
• Device Sequence Number: 3414943
• Product Code: FPA
• UDI-Device Identifier: 10885403235023
• UDI-Public: 10885403235023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 11/26/2022
• Device Model Number: 2300E-0500
• Device Catalogue Number: 2300E-0500
• Device Lot Number: 19116528
• 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: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1