MAUDE Adverse Event Report: CAREFUSION SMARTSITE ADD-ON BAG ACCESS DEVICE; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	10013365
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
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 a tubing leak.
Additional Manufacturer Narrative
Although requested, patient demographics section a (a.1-a.4) were not provided.The nurse was female, with the initial t.
Event or Problem Description
It was reported that etoposide leaked from the tubing and a nurse was exposed to the chemotherapy when she inverted the bag to contain the spill.As a result, the etoposide ran down her arm.The spill was cleaned up per facility protocol, and no skin irritation or adverse effects were reported by the nurse.

• Brand Name: SMARTSITE ADD-ON BAG ACCESS DEVICE
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9080274
• Report Number: 9616066-2019-02658
• Device Sequence Number: 16817537
• Product Code: FPA
• UDI-Device Identifier: 07613203010412
• UDI-Public: 7613203010412
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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: 10013365
• Device Catalogue Number: 10013365
• 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: 09/18/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1