MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,ADMINISTRATION,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	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Materials management.
Event or Problem Description
It was reported that the set leaked lactated ringers at the connection site during patient use.The patient's iv remained in place, and the extension set was replaced.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report that the set leaked was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed the set was received with blood at the male luer end.It was also observed that the piston base of the maxplus was not fully seated inside the maxplus component.Functional testing replicated a leak from the maxplus port.The root cause of the misassembly is due to a machine error during the manufacturing process.
Event or Problem Description
It was reported that the set leaked lactated ringers at the connection site during patient use.The patient's iv remained in place, and the extension set was replaced.There was no patient harm reported as a result of this event.
Event or Problem Description
It was reported that the set leaked lactated ringers at the connection site during patient use.The patient's iv remained in place, and the extension set was replaced.There was no patient harm reported as a result of this event.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8698568
• Report Number: 9616066-2019-01615
• Device Sequence Number: 2472956
• Product Code: FPA
• UDI-Device Identifier: 10885403237287
• UDI-Public: 10885403237287
• Combination Product (Y/N): N
• Initial Reporter Country: GA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 10/19/2019; 10/28/2019
• 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: 2426-0500, TD (B)(6) 2019; 2426-0500, TD (B)(6) 2019