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

Model Number	C25012
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to chemotherapy contamination, no product will be returned.A picture of the affected tubing set has been received.The customer complaint was confirmed by visual inspection of the provided picture.The root cause of this failure was not identified.Patient age and dob requested but not provided.
Event or Problem Description
It was reported that during a chemotherapy infusion of blincyto infusing at a rate of 10ml/hour that the anti-siphon valve leaked at connection to the non-pvc tubing set approximately 16 hours after the initiation of the chemotherapy infusion on (b)(6) 2019.The anti-siphon valve was pre-primed with a pre-filled syringe prior to connecting it to the tubing set.
Event or Problem Description
It was reported that during a chemotherapy infusion of blincyto infusing at a rate of 10ml/hour that the anti-siphon valve leaked at connection to the non-pvc tubing set approximately 16 hours after the initiation of the chemotherapy infusion on (b)(6) 2019.The anti-siphon valve was pre-primed with a pre-filled syringe prior to connecting it to the tubing set.
Additional Manufacturer Narrative
The customer¿s report of anti-siphon valve leaking at the connection to the mating device was not confirmed.A photo of the set was received, leak could not be confirmed based on the photo.The root cause was not identified.

• Brand Name: EXTENSION ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8679385
• Report Number: 9616066-2019-01552
• Device Sequence Number: 19288168
• 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): 07/02/2019

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: 06/07/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: PRI TUBING, 8015,8100 TD (B)(6) 2019; PRI TUBING, 8015,8100 TD (B)(6) 2019