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

Model Number MV0513

Device Problem Contamination (1120)

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

It was reported while using bd smartsite¿ vialshield closed vial access device, 13 mm the stopper fell into the vial.There was no report of patient impact.The following information was provided by the initial reporter: the rubber stopper was pushed out when the adapter was inserted and fell into the bottle.The adapter was inserted straight, in the center, and with a slight twisting motion into the rubber membrane.

Manufacturer Narrative

The manufacturing location for this product is yukon medical llc.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in sections manufacturer name, city and state and mfr site and the (b)(4) fda registration number has been used for the manufacture report number.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for evalution?: yes.D.10.Returned to manufacturer on: 02-aug-2022 h.6.Investigation summary: one (b)(4)sample for lot 212048 was received without packaging for investigation; the sample was received with an empty medication vial attached to the device.A visual inspection of the vial confirmed the customer's experience with the rubber septum visibly separated at the base of the vial.A closer inspection of the septum appears to indicate that the vial had been attempted to be accessed outside of the target piercing area of the vial.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 212048 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.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the (b)(4)set in the past 12 months.

Event Description

It was reported while using bd smartsite¿ vialshield closed vial access device, 13 mm the stopper fell into the vial.There was no report of patient impact.The following information was provided by the initial reporter: the rubber stopper was pushed out when the adapter was inserted and fell into the bottle.The adapter was inserted straight, in the center, and with a slight twisting motion into the rubber membrane.

• Brand Name: BD SMARTSITE¿ VIALSHIELD CLOSED 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: 15135964
• MDR Text Key: 302287845
• Report Number: 2243072-2022-01027
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10885403228100
• UDI-Public: 10885403228100
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K132863
• 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: 08/11/2022

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
• Device Operator: Other
• Device Model Number: MV0513
• Device Catalogue Number: MV0513
• Device Lot Number: 212048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 09/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• 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