MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE 30ML; SYRINGE, PISTON

Model Number	MY8030
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The texium needle-free 30ml syringe was received with two smartsite vial-shield(s) as an unexpected return, with unspecified issues and no indication of a failure mode.
Additional Manufacturer Narrative
Additional information provided in section(s): b.5, & h.6.(patient and device code).
Event or Problem Description
Texium needle-free 30ml syringes were received with products from a different complaint as an unexpected return, possible leakage from the barrel of the texium syringe when pushing medication into the iv bag prior to patient use.Although requested, there was no further patient or event information available from the customer.
Additional Manufacturer Narrative
An unexpected return from the customer confirmed a crack in the received texium syringe.The syringe was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection found a crack in the syringe barrel near the male luer tip of the syringe.Closer inspection under a lab microscope did not observe any tool marks or scratch marks on the received texium syringe.No further testing was performed due to the crack in the syringe barrel and the obvious leaking that would occur.No anomalies were observed with the two received vialshields.The root cause of the syringe crack damage could not be determined.
Event or Problem Description
The texium needle-free 30ml syringe was received with two smartsite vial-shield(s), as an unexpected return, with unspecified issues and no indication of a failure mode.Although requested, there has been no further patient or event information made available to date.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE 30ML
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9310026
• Report Number: 9616066-2019-03225
• Device Sequence Number: 13562409
• Product Code: FMF
• UDI-Device Identifier: 10885403230523
• UDI-Public: 10885403230523
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K071108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2019

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: MY8030
• Device Catalogue Number: MY8030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/28/2020; 01/30/2020
• 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)MV0520, THERAPY DATE UNKNOWN