MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE, 10 ML; SYRINGE, PISTON

Model Number	MY8010
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: etoposide 500mg/25ml, teva ndc 0703-5656-01, lot 31326913b, exp 4/22.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.Etoposide residue found on the smartsite of the 20mm vialshield after drawing up drug and disconnecting the texium bonded syringe from vialshield.Syringe tip wiped with an alcohol swab to remove residue.Etoposide residue found on the smartsite bag access of the texium infusion set after injecting etoposide into the smartsite bag access with the texium bonded syringe.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 20mm vialshield after drawing up drug and disconnecting the texium bonded syringe was confirmed after review of the picture evidence the customer provided.The texium syringe was visually inspected for cracks, holes/tears or damages to the components.Visual inspection observed no residue with the received texium.Functional testing did not find any leaks or replicate any instances of residue when activating and deactivating the mating components between the texium syringe and lab vial access device.The customer did not send in the texium infusion set or the vialshield.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.Etoposide residue was found on the smartsite of the 20mm vialshield after drawing up drug, and disconnecting the texium bonded syringe from the vialshield.Syringe tip was wiped with an alcohol swab to remove residue.Etoposide residue was found on the smartsite bag access of the texium infusion set after injecting etoposide into the smartsite bag access with the texium bonded syringe.This event occurred in the pharmacy and there was no patient involvement.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE, 10 ML
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9288170
• Report Number: 9616066-2019-03102
• Device Sequence Number: 11246399
• Product Code: FMF
• UDI-Device Identifier: 10885403221675
• UDI-Public: 10885403221675
• 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: 12/26/2021
• Device Model Number: MY8010
• Device Catalogue Number: MY8010
• Device Lot Number: 91833002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• 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: MV0520,10013361T, THERAPY DATE (B)(6) 2019