MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE, 3 ML; SYRINGE, PISTON

Model Number	MY8003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that a leak occurred between the syringe 3ml and the bonded texium connector during a velcade injection.The customer further stated that there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
The customer¿s report that leakage occurred during the injection between the syringe and texium was not confirmed.The texium bonded syringe was visually inspected for incomplete bonding engagements or damages to the components.Visual inspection did not observe any damages, tool marks, or anomalies.Functional testing resulted in no leaking.Pressure testing also found no anomalies with the returned product.The root cause of the customer¿s report was not identified.
Event or Problem Description
It was reported that a leak occurred between the syringe 3ml and the bonded texium connector during a velcade injection.The customer further stated that there were no adverse effects caused to the patient from the event.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE, 3 ML
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9234433
• Report Number: 9616066-2019-02971
• Device Sequence Number: 2483703
• Product Code: FMF
• UDI-Device Identifier: 10885403221651
• UDI-Public: 10885403221651
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071108
• 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): 09/27/2019

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: MY8003
• Device Catalogue Number: MY8003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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: NON-BD NEEDLE AND NEEDLE GUARD, TD 9/24/19