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

Catalog Number MV0420-0006

Device Problems Break (1069); Incomplete or Inadequate Connection (4037)

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

Event Date 01/13/2022

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.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 the bd smartsite¿ vented vial access device, 20 mm experienced component separation.The following information was provided by the initial reporter: vva 20mm had the luer lock connector snap off the top after attachment to a vial.This meant that the drug could not be extracted from the vial safely.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2022-01-24.Investigation summary one mv0420-0006 sample was received in opened packaging from lot 202044; the sample was received connected to a paclitaxel vial containing residual medication.A visual inspection of the product confirmed the customer's experience, as the smartsite component was received separated from the vial access device.There appeared to be residual solvent around the vad where the smartsite had been detached.A closer inspection of the smartsite identified that the body of the smartsite was discoloured suggesting that it had been subjected to a significant amount of alcohol.The details of this feedback were shared with the legal manufacturer of the product, yukon medical llc, for investigation.A definitive root cause for the observed separation could not be determined, however it is possible that it occurred as a result of an inconsistent or insufficient application of glue, coupled with the twisting force during engagement or disengagement of the smartsite.A review of the production records from lot 202044 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mv0420-0006 set in the past 12 months.

Event Description

It was reported that the bd smartsite¿ vented vial access device, 20 mm experienced component separation.The following information was provided by the initial reporter: vva 20mm had the luer lock connector snap off the top after attachment to a vial.This meant that the drug could not be extracted from the vial safely.

• Brand Name: BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 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: 13419407
• MDR Text Key: 287194599
• Report Number: 2243072-2022-00126
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/14/2022

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 Expiration Date: 10/29/2023
• Device Catalogue Number: MV0420-0006
• Device Lot Number: 202044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• 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