MAUDE Adverse Event Report: CAREFUSION MAXPLUS CLEAR NEEDLE-FREE CONNECTOR(S) EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	MPX9102-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.No investigation was performed.Although requested, patient demographics not provided.
Event or Problem Description
It was reported that the maxplus extension set leaked in the er.There was no harm.
Event or Problem Description
It was reported that the maxplus extension set leaked in the emergency room.It was further confirmed during follow-up, that there was no patient harm as a result of this event.
Additional Manufacturer Narrative
Supplemental created to revise e3 to nurse and revise e2 to yes/healthcare professional.
Additional Manufacturer Narrative
The customer¿s report that the set leaked was confirmed.Functional testing replicated a leak from the maples ports.Visual inspection observed that the piston base was not fully seated correctly.Since the maples piston was not fully seated correctly a fluid path at the base of the piston was allowing fluid to leak.Functional testing was performed by filling a lab syringe with bleach water and attaching it to the set ports allowing fluid to flow through by administering a flush.The set leaked from at the engagement between the tubing and base of the maples component where the piston was not fully seated.The source of the leak is due to the maples piston not being fully seated.The root cause of the maples piston not being seated fully is due to a machine error during the manufacturing process.
Event or Problem Description
It was reported that the maxplus extension set leaked in the er.There was no harm.

• Brand Name: MAXPLUS CLEAR NEEDLE-FREE CONNECTOR(S) EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8785882
• Report Number: 9616066-2019-01924
• Device Sequence Number: 16570969
• Product Code: FPA
• UDI-Device Identifier: 10885403237287
• UDI-Public: 10885403237287
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2019

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: MPX9102-C
• Device Catalogue Number: MPX9102-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/27/2019; 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1