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 Patient Involvement (2645)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: velcade 3.5mg/vial, millennium ndc 63020-049-01, lot 227905, exp 2/22.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
It was reported that a texium syringe had major employee safety and patient safety concerns.Velcade residue found on the smartsite of the 13mm vial access device after drawing up drug and disconnecting the texium bonded syringe from the device.This event occurred in the pharmacy and there was no patient involvement.
Additional Manufacturer Narrative
The customer¿s report that residue was found on the smartsite of the vial access device after drawing up drug and disconnecting the texium bonded syringe was confirmed after review of the picture evidence the customer provided.The vial access device was visually inspected for cracks, holes/tears or damages to the components.Visual inspection observed no residue with the received vial access device.Functional testing did not find any leaks or replicate any instances of residue when activating and deactivating the mating components between the lab texium syringe and vial access device.The customer did not send in the texium syringe that was being used during this event.The root cause of the customer¿s report could not be determined because no leftover residue was replicated during internal lab testing.
Event or Problem Description
It was reported that a texium syringe had major employee safety and patient safety concerns.Velcade residue was found on the smartsite of the 13mm vial access device after drawing up drug, and disconnecting the texium bonded syringe from the device.This event occurred in the pharmacy and there was no patient involvement.

• 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: 9288497
• Report Number: 9616066-2019-03110
• Device Sequence Number: 1935221
• Product Code: FMF
• UDI-Device Identifier: 10885403221651
• UDI-Public: 10885403221651
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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 Expiration Date: 01/21/2022
• Device Model Number: MY8003
• Device Catalogue Number: MY8003
• Device Lot Number: 91902102
• 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: 11/06/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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: 2203E, THERAPY DATE (B)(6) 2019