MAUDE Adverse Event Report: CAREFUSION MICROBORE BI-FUSE EXTENSION SET, 2 IV CO; SET, EXTENSION, INTRAVASCULAR

Model Number	MZ9271
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
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.
Event or Problem Description
The customer reported that the patient's bedding was wet and during assessment, a fluid leak from the filter was found.A new filter was obtained and connected back to the iv fluids and the patient.There was no report of patient harm.
Event or Problem Description
The customer reported that the patient's bedding was wet and during assessment, a fluid leak from the filter was found.A new filter was obtained and connected back to the iv fluids and the patient.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of a leak from the filer was confirmed however the source of the leak is from the maxzero component and not the filter.The sets and components were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Examination under magnification observed a microchannel that was allowing fluid to leak out.Functional testing resulted in the set flushing successfully and showed no signs of leaking throughout the set.Pressure testing confirmed leaking at the female port of the maxzero component.The source of the leak is due to a microchannel found in the maxzero component.The root cause of the microchannel which creates a fluid path is due to an equipment error during the inspection and testing process during final assembly of the maxzero component.
Event or Problem Description
The customer reported that the patient's bedding was wet and during assessment, a fluid leak from the filter was found.A new filter was obtained and connected back to the iv fluids and the patient.There was no report of patient harm.

• Brand Name: MICROBORE BI-FUSE EXTENSION SET, 2 IV CO
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7729189
• Report Number: 9616066-2018-01184
• Device Sequence Number: 13891581
• Product Code: FPA
• UDI-Device Identifier: 10885403240744
• UDI-Public: 10885403240744
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2018

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: MZ9271
• Device Catalogue Number: MZ9271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/17/2018; 10/29/2018
• 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: PRI TUBING, 8015, 8100, (4) MZ9271, TD: (B)(6) 2018
• Patient Age: 2 MO