MAUDE Adverse Event Report: CAREFUSION 117IN 20D DEHP FREE 2 SMARTSITE & TEXIUM; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	24009-0007T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2018
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
The customer reported that the texium leaked two times from the distal end of the texium-connection site during an infusion of doxorubicin.There was no patient harm.

• Brand Name: 117IN 20D DEHP FREE 2 SMARTSITE & TEXIUM
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7997039
• Report Number: 9616066-2018-02046
• Device Sequence Number: 1488080
• Product Code: FPA
• UDI-Device Identifier: 10885403273827
• UDI-Public: 10885403273827
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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 Expiration Date: 04/13/2021
• Device Model Number: 24009-0007T
• Device Catalogue Number: 24009-0007T
• Device Lot Number: 18045847
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 59