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

Model Number	2300E-0500
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
It was reported that the smartsite access device separated from the spike.This happened 2 times on the same day with the same product lot number.There was no patient involvement nor adverse consequence related to this event.
Event or Problem Description
It was reported that the smartsite access device separated from the spike.This is the second time this happened with this same lot of product.The customer has asked whether the device is glued together or held by friction.There was no patient involvement nor adverse consequence related to this event.
Event or Problem Description
It was reported that the smartsite access device separated from the spike.This is the second time this happened with this same lot of product.The customer has asked whether the device is glued together or held by friction.There was no patient involvement nor adverse consequence related to this event.
Additional Manufacturer Narrative
The customer¿s report that the smartsite bag access device separated from the spike was confirmed.Visual inspection under magnification of the separated expected bonded engagement components observed solvent traces along the spike.When inserting the valve into the spike up to the observed solvent traces, it was observed that the valve had not been fully inserted/seated.It was observed that the valve was able to be inserted further into the spike.Dimensional analysis of the valve male luer observed it was within iso specification.The device history record for set model 2300e-0500 lot 19115302 shows the set was manufactured on 13nov2019 with a total of (b)(4) units.There were no quality notifications issued during the production build of this component.The root cause was due to likely factors of operator not following procedure, solvent dispenser malfunction, or insufficient solvent on dispenser.

• Brand Name: SMARTSITE 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: 10074768
• Report Number: 9616066-2020-01675
• Device Sequence Number: 14159766
• Product Code: FPA
• UDI-Device Identifier: 10885403235023
• UDI-Public: 10885403235023
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2020

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: 11/13/2022
• Device Model Number: 2300E-0500
• Device Catalogue Number: 2300E-0500
• Device Lot Number: 19115302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 06/02/2020; 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1