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

Model Number	C25012
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the anti-siphon valve leaked at the connection to the non-pvc tubing set.The anti-siphon valve was pre-primed with a re-filled syringe prior to connecting it to the tubing set.
Additional Manufacturer Narrative
The photo provided by the customer shows a black circle around the distal end of the primary set male luer to the connection of the female luer mating device indicating where the customer experienced the leak.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the anti-siphon valve leaked at the connection to the non-pvc tubing set.The anti-siphon valve was pre-primed with a re-filled syringe prior to connecting it to the tubing set.

• Brand Name: SMALLBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8685046
• Report Number: 9616066-2019-01556
• Device Sequence Number: 2309184
• Product Code: FPA
• UDI-Device Identifier: 10885403235610
• UDI-Public: 10885403235610
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: C25012
• Device Catalogue Number: C25012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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: 8015,PRI TUBING,8100, THERAPY DATE UNK