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	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.
Event or Problem Description
It was reported that the smartsite access device separated from the spike.This is the first 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
No product will be returned per customer.The customer complaint of a smartsite access device separation was confirmed.Although the attached photo does not represent the actual event sample for this complaint, it identifies the described smartsite access device separation location (male luer collar to spike port) as reported in associate internal file #(b)(4), manufacturer report # 9616066-2020-01675.Device history record for model 23000e-0500 lot 19115306 shows that the set was manufactured on 20 november 2019 with a total of (b)(4) units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the smartsite access device separated from the spike.This is the first 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.

• 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: 10109274
• Report Number: 9616066-2020-01845
• Device Sequence Number: 14337688
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: 11/20/2022
• Device Model Number: 2300E-0500
• Device Catalogue Number: 2300E-0500
• Device Lot Number: 19115306
• 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: 06/02/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1