MAUDE Adverse Event Report: BECTON DICKINSON BD 20MM SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE

Catalog Number MV0413-0006

Device Problem Partial Blockage (1065)

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

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility : inselspital bern, universitatsspital fur frauenheilkunde - brust und tumorzentrum 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 and the (b)(4) fda registration number has been used for the manufacture report number.There were multiple lot numbers reported to be involved.The information for each lot number is as follows : lot # : 212050 ¿ device expiration date : 30-sep-2024 ¿ device manufacture date : 06-apr-2022 lot # : 212060 ¿ device expiration date : unknown ¿ device manufacture date : unknown.Lot # : 212023 ¿ device expiration date : 27-may-2024 ¿ device manufacture date : 21-nov-2021.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 12 bd 20mm smartsite¿ vialshield closed vial access devices had flow issues.The following information was provided by the initial reporter : the customer reported that not enough cytostatics can be removed from the bottles with the adapters resulting in a large volume loss.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval: yes.D.10.Returned to manufacturer on: 27-jun-2022.H.6.Investigation summary: twelve mv0413-0006 samples were received without packaging for investigation, the customer has indicated that the samples were from lots 212050, 212060 and 212023.All twelve samples were received with vials containing medication attached to the devices.A visual inspection of the returned samples identified that the spike of the vial access device (vad) had not fully penetrated the septum of the vial in three of the samples, with one of those samples having the bung pushed fully into the vial; this sample was not possible to test further in order to replicate the event.Functional testing was then performed with a retained bd syringe and in nine of the samples there was no observable fluid restriction with the same volume of fluid injected into the vial being drawn into the syringe.For the remaining two samples a visual inspection identified that the vial septum had been accessed outside of the target piercing area, with the spike of one of the vad noted to have been bent.The details of this feedback were shared with the legal manufacturer of the product, yukon medical llc, for investigation.A definitive root cause could not be determined as no issues were observed during testing regarding fluid being left within the vial during aspiration.However in three of the samples it was noted that the spike had not correctly accessed the septum of the vial, with one of the spikes identified to have been bent.A review of the production records for lots 212050, 212060 and 212023 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.H3 other text : see h.10.

Event Description

It was reported that 12 bd 20mm smartsite¿ vialshield closed vial access devices had flow issues.The following information was provided by the initial reporter: the customer reported that not enough cytostatics can be removed from the bottles with the adapters resulting in a large volume loss.

• Brand Name: BD 20MM SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE
• Type of Device: VIAL ACCESS DEVICE
• 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: 14780888
• MDR Text Key: 301344352
• Report Number: 2243072-2022-00841
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• 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: 212023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• 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