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

Model Number	20029E
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
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.
Event or Problem Description
The customer reported the product possibly leaked during patient use.No additional information is available.
Additional Manufacturer Narrative
The customer report of a possible leak was confirmed at the filter¿s vent.The extension set was visually inspected for obvious damage such as cracks, kinks, holes, and tears in the tubing and its components.No anomalies or evidence of damage were observed upon visual inspection.Functional testing was performed by using a bd 10ml lab syringe filled with blue dye water.After attaching the syringe to the extension set¿s female luer, the set was flushed and immediately observed a small droplet leaking from the filter¿s air vent (termed ¿weeping out¿).The extension set was pressure tested while submerged underwater, air pressure was incrementally increased.At 3 psi, a leak was observed at filter¿s vent, confirming the customer¿s report.Pressure was increased to 30 psi but no other leaks were observed.The root cause of the leak was not identified.
Event or Problem Description
The customer reported the product possibly leaked during patient use.No additional information is available.

• 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: 8364802
• Report Number: 9616066-2019-00442
• Device Sequence Number: 1697798
• Product Code: FPA
• UDI-Device Identifier: 10885403234866
• UDI-Public: 10885403234866
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: 1 CUROS DISINFECTING CAP, TD UNK