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

Model Number	MZ9324
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
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Concomitant medical product:(2) maxzero needle-free connector.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.
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.
Additional Manufacturer Narrative
The customer¿s report that the extension set was leaking at the base of the filter was confirmed however the leak is from the filter's weld line and not from a crack as reported.Visual inspection of the set showed no damage or any anomalies.Closer inspection under magnification showed no cracks, tool marks or stress marks on the filter component.Functional testing confirmed leaking from the filter side weld line.The root cause of the customer¿s report is a supplier manufacturing issue.

• 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: 8236172
• Report Number: 9616066-2019-00045
• Device Sequence Number: 16431105
• Product Code: FPA
• UDI-Device Identifier: 10885403427237
• UDI-Public: 10885403427237
• 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,Followup
• 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: MZ9324
• Device Catalogue Number: MZ9324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ME2017, UMBILICAL VENOUS CATHETER, TD: UNK.