MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,EXTENSION,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	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer reported that the cap leaks when iv was hooked up.No patient harm was reported.
Event or Problem Description
The customer reported that the needle-free connector on the extension set leaks when the iv was hooked up.They noticed the hub was 'crooked' which they felt caused the leak.No patient harm was reported.
Additional Manufacturer Narrative
The customer report of a leak was confirmed.Visual inspection showed no anomalies.Functional testing showed a leak from the engagement of the needleless valve and the luer entrance of the set.Both valves were carefully cut open where the valve top and base components meet and a tear was observed on each of the silicone valve components.The cause of the leak was due to damaged silicone valve components within the maxplus valves.The potential root cause of the damages were identified to have occurred during the valve component¿s assembly/automated process.

• Brand Name: EXTENSION SET
• Common Device Name: SET,EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7866881
• Report Number: 9616066-2018-01647
• Device Sequence Number: 11154760
• 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: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: 09/11/2018
• Supplement Report FDA Received Date: 01/30/2019
• 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: MP1000-C, TD (B)(6) 2018; PRI TUBING, TD (B)(6) 2018