MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 20MM; SET, IV FLUID TRANSFER

Model Number	MV0520
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported bd smartsite¿ vialshield closed vial access device, 20mm had fluid drawn into the vent.The following information was provided by the initial reporter: pharmacist called and while preparing chemotherapy the fluid was drawn into the vent and medication during use with the access adapter.
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 bd smartsite¿ vialshield closed vial access device, 20mm had fluid drawn into the vent.The following information was provided by the initial reporter: pharmacist called and while preparing chemotherapy the fluid was drawn into the vent and medication during use with the access adapter.
Additional Manufacturer Narrative
One sample was submitted for quality investigation.The customer complaint of component damage - no leak was verified by visual inspection.The sample submitted showed evidence of the chemotherapy liquid in the vapor collection portion of the vialshield product.The sample was then forwarded to the supplier for further evaluation.The supplier investigation verified that the fluid was in the bell of the vialshield product.Failure modes such as, a hole in the filter and an issue with a faulty seal between the lower and upper housing, that could allow for fluid to enter into the bell, were investigated.Both of these issues were not found to be the cause during the investigation.Further investigation by the supplier indicates that the only way they could reproduce the failure reported is injecting while the vial is inverted.The supplier reported that there were there were no non-conforming material reports, corrective and preventative actions / deviations generated or reported anomalies during the production of this lot.There have been no other complaints associated with this lot.Based on the investigation conducted by the supplier on the sample submitted, the root cause for the failure is an improper use of the product.The supplier indicates that because the vialshield was used inverted, it allowed for liquid to enter the vapor collection portion of the product.H3 other text : see h10.

• Brand Name: BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 20MM
• 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: 14465124
• Report Number: 2243072-2022-00720
• Device Sequence Number: 4904276
• Product Code: LHI
• UDI-Device Identifier: 10885403228117
• UDI-Public: 10885403228117
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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 Expiration Date: 11/11/2024
• Device Model Number: MV0520
• Device Catalogue Number: MV0520
• Device Lot Number: 212075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2021
• 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