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

Catalog Number MV0413-0006

Device Problems Leak/Splash (1354); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2022

Event Type  malfunction  

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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #: an invalid lot # of 202016 was provided by the initial reporter.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 Description

It was reported that the bd smartsite¿ vented vial access device, 13 mm experienced a protector that would not fit the vial resulting in leakage.The following information was provided by the initial reporter: smartsite vented vial access device did not connect correctly to the vial.When the syringe was attached to the access device the solution in the vial could not be withdrawn.When the access device was adjusted to try and correct the positioning the bung of the vial disconnected completely from the vial top and the solution inside the vial leaked out.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2022-02-22/.Investigation summary one mv0413-0006 sample from lot 202016 was received for investigation in opened packaging for investigation.The customer reported that the vial septum had been pushed into the vial and that the solution then leaked out from between the vial and the mv0413-0006 device.The sample was connected to a 25ml vial of pembrolizumab.A visual inspection identified that the smartsite was received separated from the vial access device, a closer inspection identified that the tip of the male luer of the smartsite was still solvent bonded within the vial access device.A visual inspection of the vial confirmed that the septum of the vial had been pushed into the vial; a closer inspection indicates that the spike of the vial access device appeared to have accessed the septum outside of the target piercing area.The details of this feedback were shared with the legal manufacturer of the product, yukon medical llc, for investigation.A review of the production records from lot 202016 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A definitive root cause for the septum being pushed into the vial could not be determined, however previous investigations have replicated this failure mode if the vial septum is pierced off-center of the target piercing area.Please note that the spike of the vented vial adaptor device is intended to be inserted at the central circle position of the vial's septum using a vertical force.During analysis of the returned vial access device, it was noted that the smartsite was observed to have been snapped off from the component; previous investigations have confirmed that this type of damage can occur as a result of a lateral force being applied to the component, the root cause of which could not be determined during the investigation.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mv0413-0006 set in the past 12 months.H3 other text : see h10.

Event Description

It was reported that the bd smartsite¿ vented vial access device, 13 mm experienced a protector that would not fit the vial resulting in leakage.The following information was provided by the initial reporter: smartsite vented vial access device did not connect correctly to the vial.When the syringe was attached to the access device the solution in the vial could not be withdrawn.When the access device was adjusted to try and correct the positioning the bung of the vial disconnected completely from the vial top and the solution inside the vial leaked out.

• Brand Name: BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 MM
• Type of Device: 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: 13371443
• MDR Text Key: 287195197
• Report Number: 2243072-2022-00090
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MV0413-0006
• Device Lot Number: 202016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1