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	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: qty (b)(4)- etoposide 100mg/5ml, accord ndc 16729-114-31, lot: x17311, exp: 08/20 and x17312, exp 8/20.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 smartsites of the 13mm vial access devices after drawing up the drug and disconnecting the texium bonded syringe from the devices.Residue was wiped off the syringe tip with an alcohol pad prior to injecting into bag, 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.
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 smartsites of the 13mm vial access devices after drawing up the drug, and disconnecting the texium bonded syringe from the devices.Residue was wiped off the syringe tip with an alcohol pad prior to injecting into the bag.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.
Additional Manufacturer Narrative
Additional information added; d.10.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 texium syringe and vial access devices were visually inspected for cracks, holes/tears or damages to the components.Visual inspection observed no residue with the received texium or vial access devices.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 vial access devices.The customer did not send in the texium infusion set.The root cause of the customer¿s report could not be determined because no leftover residue was replicated during internal lab testing.

• 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: 9287634
• Report Number: 9616066-2019-03100
• Device Sequence Number: 11288795
• 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: (2) 2203E,10013361T, THERAPY DATE (B)(6) 2019.