MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE; SET, IV FLUID TRANSFER

Model Number	MV0520
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd smartsite¿ vialshield closed vial access device experienced component separation and leakage.The following information was provided by the initial reporter: lead chemo tech experienced breakage of the syringe luer tip that resulted in leakage of the chemotherapy medication.
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of separation could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE
• Common Device Name: SET, IV FLUID TRANSFER
• 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: 15480635
• Report Number: 2243072-2022-01621
• Device Sequence Number: 15163381
• Product Code: LHI
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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
• Report Date (Section B): 09/12/2022

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: UNKNOWN
• 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: 08/30/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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