MAUDE Adverse Event Report: CAREFUSION SMARTSITE VIALSHIELD CLOSED VIAL ACCESS DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MV0520
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: paclitaxel injection vial, lot: 9az5231, exp: 06/2022.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 the closed vial access device (cvad), attached to a paclitaxel 50ml vial, separated while the pharmacy technician was unscrewing the texium syringe from the cvad.The leak did not cause harm to the pharmacy technician.There was no patient involvement as the event occurred while the medication was being prepared in the pharmacy department.
Additional Manufacturer Narrative
The customer¿s report that the closed vial access device (cvad) separated while the pharmacy technician was unscrewing the texium syringe was confirmed by visual inspection.The received products were visually inspected for obvious damage such as incomplete bonding engagements, cracks, fractures or other anomalies.The smartsite component which should be bonded to the cvad had separated from the cvad and was still connected to the texium syringe.There were no physical signs of breakage or stress on the cvad or smartsite.However, the threads of the smartsite¿s female luer adapter were turned upwards at the edges indicating over-tightening.Investigation found marginal solvent between the male/female threads of the mating parts.Functional testing was not performed due to the obvious damage on the received vad.The root cause for the separation could not be definitively determined.Yukon medical device history record review: a device history record review was completed for mv0520 lot 9242.There were no nmrs, capas/deviations generated or reported anomalies during the production of this lot.The date of manufacture is 10/2019.
Event or Problem Description
It was reported that the closed vial access device (cvad), attached to a paclitaxel 50ml vial, separated while the pharmacy technician was unscrewing the texium syringe from the cvad.The leak did not cause harm to the pharmacy technician.There was no patient involvement as the event occurred while the medication was being prepared in the pharmacy department.

• Brand Name: SMARTSITE VIALSHIELD CLOSED VIAL ACCESS DEVICE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9740150
• Report Number: 9616066-2020-00570
• Device Sequence Number: 3098518
• Product Code: FPA
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K132863
• 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
• Report Date (Section B): 02/04/2020

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: MV0520
• Device Catalogue Number: MV0520
• Device Lot Number: 9242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 08/03/2020
• 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: 2000E,MY8020, THERAPY DATE UNKNOWN