MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. SMARTSITE VIALSHIELD 20MM CLOSED VAD; VIAL ACCESS DEVICE

Model Number	MV0520
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the smartsite vialshield 20mm closed vad experienced leakage, component separation, and device damage/deformation.The following information was provided by the initial reporter: carefusion vialshield 20 mm device is part of a closed system transfer device to be used in the preparation of chemotherapy in a pharmacy the connections on the device are supposed to be sealed by glue and were separating once a syringe was attached this occurred with 2 products and a 3rd one broke at the connection and lead to a small chemo spill staff was instructed to hold device at the connection to assume it wasn't sealed at manufacturer's product was intended.
Additional Manufacturer Narrative
Due to no photo or sample being received, the customer's complaint of leakage could not be verified.A device history record review could not be performed because an accurate lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that the smartsite vialshield 20mm closed vad experienced leakage, component separation, and device damage/deformation.The following information was provided by the initial reporter: carefusion vialshield 20 mm device is part of a closed system transfer device to be used in the preparation of chemotherapy in a pharmacy the connections on the device are supposed to be sealed by glue and were separating once a syringe was attached this occurred with 2 products and a 3rd one broke at the connection and lead to a small chemo spill staff was instructed to hold device at the connection to assume it wasn't sealed at manufacturer's product was intended.

• Brand Name: SMARTSITE VIALSHIELD 20MM CLOSED VAD
• Common Device Name: VIAL ACCESS DEVICE
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10423111
• Report Number: 9616066-2020-02463
• Device Sequence Number: 4060595
• Product Code: LHI
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: MV0520
• Device Catalogue Number: MV0520
• Device Lot Number: 0205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other