MAUDE Adverse Event Report: CAREFUSION ALARIS NO PORT EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	11088483
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer report of a leak at the needleless connector during a flush was confirmed based on testing performed on the as-received samples.It was observed there was a leak at the connection area of the smartsite valve and extension set's female luer components.The leaking connection area was carefully detached from each other and the connection felt loose.Inspection of the mated components also observed no obvious damages or issues and were within specification.The recently mated components were reattached and testing redone.No fluid leak was observed, however; a leak during pressure testing was observed.The root cause was identified as due to a discontinuous surface contact caused by a molding defect in the extension set's female luer component.
Event or Problem Description
It was reported that a leak at the needleless connector occurred during a 10 ml normal saline flush.The rn further stated during follow-up that there was no other event details or patient demographics available, other than what was sent with the product.

• Brand Name: ALARIS NO PORT EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9284537
• Report Number: 9616066-2019-03135
• Device Sequence Number: 19680310
• Product Code: FPA
• UDI-Device Identifier: 10885403234668
• UDI-Public: 10885403234668
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

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: 11088483
• Device Catalogue Number: 11088483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1