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

Catalog Number MV0420-0006

Device Problem Crack (1135)

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

Event Date 01/06/2022

Event Type  malfunction  

Event Description

It was reported 3 bd smartsite¿ vented vial access devices, 20 mm suffered vial breakage when assembling the protector.The following information was provided by the initial reporter: "bottle cracked when pulling on, after piercing the adapter.

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.Date of event: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 212023, medical device expiration date: 05/27/2024, device manufacture date: 10/08/2021.Medical device lot #: 212036, medical device expiration date: 08/19/2024, device manufacture date: 09/24/2021.The reported lot # 212037 was not found for the reported catalog #.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation: a mv0420-0006 product was not available for investigation; however the customer confirmed that the complaint sample was from lot 212023, 212037 or 212036.Further information provided by the customer indicates that the leakage was observed between the vial and the mv0420-0006 device during attempted use.A review of the production records from lots 212023, 212037 or 212036 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 customer¿s experience.

Event Description

It was reported 3 bd smartsite¿ vented vial access devices, 20 mm suffered vial breakage when assembling the protector.The following information was provided by the initial reporter: "bottle cracked when pulling on, after piercing the adapter.

• 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: 13347325
• MDR Text Key: 287012574
• Report Number: 2243072-2022-00064
• 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: 02/28/2022

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 H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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