MAUDE Adverse Event Report: CAREFUSION SMARTSITE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	30262E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Although requested, patient demographics was not provided.
Event or Problem Description
It was reported that the extension tubing was leaking at the connection.Although requested, additional information was not provided.
Event or Problem Description
It was reported that the extension tubing was leaking at the connection.Although requested, there has been no impact to patient response or additional event information made available to date.
Additional Manufacturer Narrative
The customer¿s report that the extension tubing was leaking at the connection was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed a lateral crack in the female luer wall near the inlet port proximal to the check valve.No signs of over torque or other issues were observed.Functional testing was performed; the set leaked from the cracked female luer.No other leaks were observed throughout the set.The root cause of the crack was a result of internal stresses created during the manufacturing process.

• Brand Name: SMARTSITE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9608477
• Report Number: 9616066-2020-00204
• Device Sequence Number: 2677919
• Product Code: FPA
• UDI-Device Identifier: 07613203011471
• UDI-Public: 7613203011471
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 12/19/2019

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: 30262E
• Device Catalogue Number: 30262E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1