MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET

Model Number	2478-0000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 that on multiple occasions there was a leak which occurred around the extra port when the blood tubing was primed.There was no specific information given for the events.There was no patient harm.
Event or Problem Description
The customer reported that on multiple occasions there was a leak which occurred around the extra port when the blood tubing was primed.There was no specific information given for the events.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of leaking around the ¿extra port¿ was confirmed.Visual inspection of the set noted no discernible damage or abnormalities.Examination under magnification of the area of separation revealed an uneven and scant distribution of bonding solvent on the separated tubing edge.Functional testing resulted in the tubing bonded into the inlet of the y-site smartsite was easily separated from the component.The cause of the separation and reported leak was determined to be an insufficient bonding solvent application during manufacture of the set.

• Brand Name: NON-VENTED BLOOD SET
• Common Device Name: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7848237
• Report Number: 9616066-2018-01575
• Device Sequence Number: 1535759
• Product Code: FPA
• UDI-Device Identifier: 10885403235122
• UDI-Public: 10885403235122
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• 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
• Report Date (Section B): 08/09/2018

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 Model Number: 2478-0000
• Device Catalogue Number: 2478-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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: O POSITIVE BLOOD BAG, THERAPY DATE UNK