MAUDE Adverse Event Report: CAREFUSION ALARIS NON-DEHP STND BORE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	MX9166
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report of a leak coming from the back side of the filter from the built-in "circle area" was confirmed based on functional and pressure testing.It was observed that fluid leaked out (termed ¿weeping out¿) from the vent of the extension set¿s 0.2 micron filter.Although the root cause was not definitively determined, the probable identified cause of the observed filter vent leak was due to clog/oversaturation of filter and the time of use from which the fluid flow was restricted.The fluid then seeks the path of least resistance through the filter vents.The set was visually inspected for obvious damage such as cracks, kinks, holes, and tears in the tubing and its components.Sticky residue was also observed on the surface of the set¿s filter.No anomalies or evidence of damage were observed on the filters or the sets upon visual inspection.The root cause of the leak was not identified.
Event or Problem Description
It was reported that there is a leak coming from the back side of the filter from the built-in "circle area".It was also confirmed that there was no patient harm as a result of this event.

• Brand Name: ALARIS NON-DEHP STND BORE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9198307
• Report Number: 9616066-2019-02893
• Device Sequence Number: 10865169
• Product Code: FPA
• UDI-Device Identifier: 10885403237652
• UDI-Public: 10885403237652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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
• Report Date (Section B): 09/20/2019

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 Expiration Date: 01/30/2024
• Device Model Number: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: 19017181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1