MAUDE Adverse Event Report: YUKON MEDICAL SMARTSITE 20MM CLOSED VIAL ACCESS DEVICE; SET, I.V. FLUID TRANSFER

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	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the closed vial access device (cvad) separated while the pharmacy technician was unscrewing the texium syringe from the cvad attached to rituximab vial.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
Cont¿d d.11: genentech, 100mg/vial, lot 3346609, exp.03/2022.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 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.No other damage or anomalies were observed.Supplier investigation found marginal solvent between the male/female threads of the mating parts.Functional testing was not performed due to the obvious separation.A device history record review was completed for mv0520 lot 9244.There were no nmrs, capas/deviations generated or reported anomalies during the production of this lot.The root cause could not be definitively determined.
Event or Problem Description
It was reported that the closed vial access device (cvad) separated while the pharmacy technician was unscrewing the texium syringe from the cvad attached to rituximab vial.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 20MM CLOSED VIAL ACCESS DEVICE
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): YUKON MEDICAL; 2200 gateway centre blvd; ste 208; morrisville NC 27560 9122
• MDR Report Key: 9933436
• Report Number: 9616066-2020-01217
• Device Sequence Number: 2342080
• Product Code: LHI
• 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): 03/13/2020

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: 9244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 08/17/2020
• 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: MY8020, THERAPY DATE 03/13/2020