MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM; SET, IV FLUID TRANSFER

Model Number	MV0513
Medical Device Problem Codes	Backflow (1064); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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.
Event or Problem Description
It was reported bd smartsite¿ vialshield closed vial access device, 13 mm was damaged and had backflow issues.The following information was provided by the initial reporter: "the bcg starts to go in via the catheter and then it stops and starts backflowing back into the sodium chloride bottle on us.One of the nurses who reported the flow concerns also mentioned difficulty seating the vialshield on the nss vial.She stated that she has observed that the plastic insertion tip sometimes appears to be bent after being pushed into the nss vial.".
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.It was reported that the product backflow and the plastic insertion tip is bent.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mv0513 because a lot number is unknown.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 bd smartsite¿ vialshield closed vial access device, 13 mm was damaged and had backflow issues.The following information was provided by the initial reporter: "the bcg starts to go in via the catheter and then it stops and starts backflowing back into the sodium chloride bottle on us.One of the nurses who reported the flow concerns also mentioned difficulty seating the vialshield on the nss vial.She stated that she has observed that the plastic insertion tip sometimes appears to be bent after being pushed into the nss vial.".

• Brand Name: BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM
• 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: 13865236
• Report Number: 2243072-2022-00378
• Device Sequence Number: 20169897
• Product Code: LHI
• UDI-Device Identifier: 10885403228100
• UDI-Public: 10885403228100
• 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): 04/19/2022

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: MV0513
• Device Catalogue Number: MV0513
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/05/2022
• 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