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

Model Number	MP5310-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/05/2019
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
It was reported that the maxplus¿ on the pressure rated extension set leaked at the connection of the bd auto guard peripheral iv site.
Event or Problem Description
It was reported that the maxplus¿ needless connector on the pressure rated extension set leaked at the connection to the bd auto guard peripheral iv site.
Additional Manufacturer Narrative
The customer report that the set leaked at the connection to the peripheral iv site was not confirmed.Visual inspection showed no anomalies.Functional testing showed no anomalies.Dimensional testing performed on the set¿s luer end was noted to be within iso specification.The root cause of the customer's report could not be identified.

• 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: 8559626
• Report Number: 9616066-2019-01118
• Device Sequence Number: 2339519
• Product Code: FPA
• UDI-Device Identifier: 10885403236686
• UDI-Public: 10885403236686
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/05/2019

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: MP5310-C
• Device Catalogue Number: MP5310-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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: (2) BD INSYTE AUTOGUARD, TD (B)(6) 2019.