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

Model Number MP9233-C

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2019

Event Type  malfunction  

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 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.

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 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8376258
• MDR Text Key: 137420022
• Report Number: 9616066-2019-00466
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403237089
• UDI-Public: 10885403237089
• Combination Product (y/n): N
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MZ1000-07,10ML BD SYRINGE, THERAPY DATE (B)(6) 2019.
• Patient Age: 4 YR