MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number	MV0520
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is yukon medical llc.This site is an oem manufacturing site.(b)(4).Device evaluated by mfr: 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 doxorubicin leaked from the bd smartsite¿ vialshield closed vial access device during use.The following information was provided by the initial reporter: "the oncology technician has brought to my attention that the texium needle free syringe is experiencing some leaking/drug exposure when using.Recently, doxorubicin was used.And the drug can clearly be seen (since drug is red).
Additional Manufacturer Narrative
Investigation summary: the customer provided three photos for investigation by our quality team.The photos were enough to verify the leak complaint but without further evidence like a physical sample for investigation, the root cause remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
It was reported that doxorubicin leaked from the bd smartsite¿ vialshield closed vial access device during use.The following information was provided by the initial reporter: "the oncology technician has brought to my attention that the texium needle free syringe is experiencing some leaking/drug exposure when using.Recently, doxorubicin was used and the drug can clearly be seen (since drug is red).

• Brand Name: BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16019494
• Report Number: 2243072-2022-02195
• Device Sequence Number: 5784615
• Product Code: FPA
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K132863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/07/2023

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 Expiration Date: 09/08/2025
• Device Model Number: MV0520
• Device Catalogue Number: MV0520
• Device Lot Number: 222101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown