MAUDE Adverse Event Report: BECTON DICKINSON SMARTSITE VIALSHIELD 20MM CLOSED VAD; VIAL ACCESS DEVICE

Model Number	MV0520
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: (b)(4).Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the smartsite vialshield 20mm closed vad had foreign matter in the expansion chamber.The following information was provided by the initial reporter: "customer states that texium vented vial adapter has some type of foreign matter which looks like a black speck inside the expansion chamber.".
Event or Problem Description
It was reported that the smartsite vialshield 20mm closed vad had foreign matter in the expansion chamber.The following information was provided by the initial reporter: "customer states that texium vented vial adapter has some type of foreign matter which looks like a black speck inside the expansion chamber.".
Additional Manufacturer Narrative
H6: investigation summary one sample was submitted for quality investigation.The sample was sent to yukon medical for further investigation with the manufacturer.The complaint of foreign matter in the bell of the device was confirmed.A device history record review could not be performed on model mv0520 because a lot number was not provided by the customer.The most probable root of entry of the contaminate into the bell is during the manufacturing of the film or during assembly of the bell.This incident has been added to our database of reported incidents.

• Brand Name: SMARTSITE VIALSHIELD 20MM CLOSED VAD
• Common Device Name: VIAL ACCESS DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10775347
• Report Number: 2243072-2020-01774
• Device Sequence Number: 1138203
• 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: K132863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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 Model Number: MV0520
• Device Catalogue Number: MV0520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1