MAUDE Adverse Event Report: CAREFUSION MAXPLUS® TRI-FUSE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MP9233-C
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer reported one of the needleless connectors on a maxplus trifuse cracked and leaked during patient use.The customer would like to know if the crack originated from the inside or the outside of the product.
Additional Manufacturer Narrative
The customer¿s report that the maxplus trifuse cracked and leaked was confirmed to be damaged maxplus port components.Visual inspection observed that the maxplus connectors were worn down and the plastic body had been weakened.Functional testing replicated leaks from two of the maxplus ports.Closer inspection under magnification of the maxplus components observed small cracks in the plastic of the maxplus body.The maxplus body was observed to be scuffed and the plastic had patches of white similarly to having been exposed to disinfecting alcohol.Based on these observations, the cracks originate from the outside of the maxplus.The root cause of the broken maxplus could not be definitively determined.
Event or Problem Description
The customer reported one of the needleless connectors on a maxplus trifuse cracked and leaked during patient use.The customer would like to know if the crack originated from the inside or the outside of the product.

• Brand Name: MAXPLUS® TRI-FUSE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8376258
• Report Number: 9616066-2019-00466
• Device Sequence Number: 16715630
• Product Code: FPA
• UDI-Device Identifier: 10885403237089
• UDI-Public: 10885403237089
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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 Model Number: MP9233-C
• Device Catalogue Number: MP9233-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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: MZ1000-07,10ML BD SYRINGE, THERAPY DATE (B)(6) 2019.
• Patient Age: 4 YR