MAUDE Adverse Event Report: CAREFUSION MAXPLUS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MPX5302-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
The customer reported a leak occurred during patient use.No patient harm was reported.
Event or Problem Description
The customer reported a leak occurred during patient use.No patient harm was reported.
Additional Manufacturer Narrative
The customer¿s report of a leak was confirmed.Functional testing was performed; a leak was observed at the attachment of the maxplus valve to the female luer.Magnified inspection showed that the source of the leak was a thin crack spanning the length of the female luer body.The root cause of the damage was not determined.

• Brand Name: MAXPLUS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7928514
• Report Number: 9616066-2018-01804
• Device Sequence Number: 11330228
• Product Code: FPA
• UDI-Device Identifier: 10885403237232
• UDI-Public: 10885403237232
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/06/2018

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 Expiration Date: 01/25/2023
• Device Model Number: MPX5302-C
• Device Catalogue Number: MPX5302-C
• Device Lot Number: 18016670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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: PRI TUBING, TD (B)(6) 2018