MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MV0413-0006

Device Problem Contamination (1120)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

It was reported while using bd smartsite¿ vented vial access device the rubber stopper bulged into the vial.There was no report of patient impact.The following information was provided by the initial reporter: the adapter cannot be pierced through the rubber.The tip of the adapter does not reach through the rubber, therefore no liquid can be removed.The rubber diaphragm bulges downward when piercing, and it pushes the rubber down too far for the down that the mandrel no longer comes out.

Manufacturer Narrative

The manufacturing location for this product is (b)(4) llc.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in manufacturer name, city and state and mfr site and the (b)(4) fda registration number has been used for the manufacture report number.Date of event is unknown; awareness date has been used for this field.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: d9: device available for eval yes, d9: returned to manufacturer on: 02-aug-2022.Investigation summary: one mv0413-0006 sample for lot 212050 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 partially detached from the top of the vial and with minimal manual manipulation, the septum fell into the vial.A closer inspection appears to indicate that the septum 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 212050 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.

Event Description

It was reported while using bd smartsite¿ vented vial access device the rubber stopper bulged into the vial.There was no report of patient impact.The following information was provided by the initial reporter: the adapter cannot be pierced through the rubber.The tip of the adapter does not reach through the rubber, therefore no liquid can be removed.The rubber diaphragm bulges downward when piercing, and it pushes the rubber down too far for the down that the mandrel no longer comes out.

• Brand Name: BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: 15135975
• MDR Text Key: 304308808
• Report Number: 2243072-2022-01026
• Device Sequence Number: 1
• Product Code: FPA
• 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: 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 Catalogue Number: MV0413-0006
• Device Lot Number: 212050
• 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: 08/11/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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