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

Model Number	10013365
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.The customer complaint of the tubing separating from spike port with leakage could not be verified due to the product not being returned for failure investigation.A device history record review for model 10013365 lot number 18034603 was performed.The search showed that a total of 11,803 units in 1 lot number was built on 08apr2018.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Root cause analysis: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Investigation conclusion: 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 add-on bag access device tubing separated and leaked.The following information was provided by the initial reporter: material no: 10013365, batch no: 18034603.It was reported tubing line completely separated when spike fell out of 50 ml bag filled with methotrexate, allowing contents to spill out.Customer email (b)(6) 2020: sorry it¿s taken a bit to get back with you.Per our safety report and speaking with staff, the contents of a 50ml methotrexate bag spilled from the spike after it fell out of a 50ml bbraun pab bag.The event was on the morning of (b)(6) 2020.No patient was harmed due to this from speaking with the charge nurse over the area, and the spill was contained and cleaned with a chemotherapy spill kit.Due to the nature of the spill, was informed the product line set and bag were disposed at time of spill cleanup.

• Brand Name: SMARTSITE ADD-ON BAG ACCESS DEVICE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10512327
• Report Number: 9616066-2020-02658
• Device Sequence Number: 3903891
• Product Code: FPA
• UDI-Device Identifier: 07613203010412
• UDI-Public: 7613203010412
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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: 03/31/2021
• Device Model Number: 10013365
• Device Catalogue Number: 10013365
• Device Lot Number: 18034603
• 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: 09/09/2020
• 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