MAUDE Adverse Event Report: CAREFUSION MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR; SET, EXTENSION, INTRAVASCULAR

Model Number	MZ9325
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.Concomitant medical product:(2) maxzero needle-free connector listed as concomitant.Event occurred in nicu on a baby.
Event or Problem Description
The customer reported that the user noted that the baby's blanket was damp.The rn placed a gauze underneath the uvc (patient umbilical venous catheter) tri-port and found it to be leaking.Upon closer observation, the "lipid line" extension set was noted to be cracked and leaking at the base of the filter.The user had to discontinued the lipid infusion and changed out the lines.The event occurred in the nicu.

• Brand Name: MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8236198
• Report Number: 9616066-2019-00046
• Device Sequence Number: 1148140
• Product Code: FPA
• UDI-Device Identifier: 10885403427244
• UDI-Public: 10885403427244
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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: MZ9325
• Device Catalogue Number: MZ9325
• 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: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1