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.
Additional Manufacturer Narrative
Supplemental created to revise e3 to nurse and e2 to yes/healthcare professional.
Event or Problem Description
It was reported that the maxplus extension set leaked in the emergency room after connecting it to the iv catheter.It was further confirmed during follow-up, that there was no patient harm as a result of this event.

• 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: 8782824
• Report Number: 9616066-2019-01935
• Device Sequence Number: 16647775
• 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: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,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 Expiration Date: 04/27/2023
• Device Model Number: MPX9102-C
• Device Catalogue Number: MPX9102-C
• Device Lot Number: 18047008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1