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

Catalog Number MV0420-0006

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

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

Event Date 01/31/2022

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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 212041 (invalid lot #).Medical device expiration date: na.Device manufacture date: na.Medical device lot #: 212049.Medical device expiration date: 2024-09-23.Device manufacture date: 2022-02-09.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 bd smartsite¿ vented vial access device, 20 mm experienced 6 cases of flow issues, and 6 cases of being clogged.The following information was provided by the initial reporter: the product presents occlusion and does not allow its use.When the product is placed in the vial and is used to extract the liquid from the inside of the vial, it is observed that it does not allow the fluid to pass through, as if it were occluded.This has occurred 6 times in the last month.There is no patient affected as it occurs during the beginning of the preparation of the treatment in the clean room of the pharmacy.

Event Description

It was reported that bd smartsite¿ vented vial access device, 20 mm experienced 6 cases of flow issues, and 6 cases of being clogged.The following information was provided by the initial reporter: the product presents occlusion and does not allow its use.When the product is placed in the vial and is used to extract the liquid from the inside of the vial, it is observed that it does not allow the fluid to pass through, as if it were occluded.This has occurred 6 times in the last month.There is no patient affected as it occurs during the beginning of the preparation of the treatment in the clean room of the pharmacy.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 29-mar-2022.Investigation summary: seven mv0420-0006 samples were received in sealed packaging for investigation; five samples were from lot 212041 and two samples from 212049.A visual inspection of the received samples did not identify any product defects or manufacturing issues which could have contributed to the customer¿s experience.Functional testing was then performed on the returned samples by connecting them to a vial from bd stock and flushing them with fluid using a 50ml bd plastipak syringe; fluid was able to be flushed into and withdrawn from the vial with no signs of occlusion or flow resistance.The customer's experience was not confirmed in this instance.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 for lots 212041 and 212049 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the customer¿s experience in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.In this instance the affected product and the connecting vial were not returned for investigation, and therefore it could not be determined if this may have contributed to the customer's experience.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 product in the past 12 months.

Manufacturer Narrative

H6: investigation summary: an mv0420-0006 product was not available for investigation; however the customer confirmed that the complaint samples were from lot 212041 or 212049.The customer reported that it was not possible to draw up fluid with the device when accessing 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 for lots 212041 and 212049 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported occlusion.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 product in the past 12 months.H3 other text : see h10.

Event Description

It was reported that bd smartsite¿ vented vial access device, 20 mm experienced 6 cases of flow issues, and 6 cases of being clogged.The following information was provided by the initial reporter: the product presents occlusion and does not allow its use.When the product is placed in the vial and is used to extract the liquid from the inside of the vial, it is observed that it does not allow the fluid to pass through, as if it were occluded.This has occurred 6 times in the last month.There is no patient affected as it occurs during the beginning of the preparation of the treatment in the clean room of the pharmacy.

• 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: 13529557
• MDR Text Key: 285676503
• Report Number: 2243072-2022-00203
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 04/06/2022

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 Catalogue Number: MV0420-0006
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 03/16/2022; 04/06/2022
• Supplement Dates FDA Received: 04/01/2022; 04/08/2022
• 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