MAUDE Adverse Event Report: CAREFUSION 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	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned.No investigation was performed.
Event or Problem Description
The customer reported that the set leaked from the vent hole on the back of the filter.There was no report of patient harm.

• Brand Name: EXTENSION SET
• Common Device Name: SET,EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8117361
• Report Number: 9616066-2018-02364
• Device Sequence Number: 19224911
• Product Code: FPA
• UDI-Device Identifier: 10885403237652
• UDI-Public: 10885403237652
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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: MX9166
• Device Catalogue Number: MX9166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1