MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 MM; SET, IV FLUID TRANSFER

Catalog Number MV0413-0006

Device Problem Complete Blockage (1094)

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

Event Date 02/11/2022

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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #: an invalid lot # of 2012023 was provided by the initial reporter.Device expiration date: unknown.Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd smartsite¿ vented vial access device, 13 mm was clogged.The following information was provided by the initial reporter: filter stuck together when drawing up.Medication could no longer be removed.Filter broken off afterwards.

Event Description

It was reported that the bd smartsite¿ vented vial access device, 13 mm was clogged.The following information was provided by the initial reporter: filter stuck together when drawing up.Medication could no longer be removed.Filter broken off afterwards.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 22-mar-2022.H6: investigation summary: one mv0413-0006 sample from lot 212023 was received without packaging for investigation, the sample was received alongside a my8010-0006 product and a vial.The mv0413-0006 sample was received broken into multiple pieces.A visual inspection of the vial identified that the spike had broken off and was slightly off center of the vial, however the spike had penetrated the vial septum.It was not possible to functionally test the mv0413-0006 sample due to the damage observed and so it was not possible to confirm the customer's experience.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 customer's experience could not be determined as it was not possible to perform functional testing on the returned vial access device, however it was noted that the spike had penetrated the vial off center and had broken away from the vial access device; in this instance it was not possible to determine when the spike breakage had occurred and whether this may have contributed to the customer's experience.A review of the production records for lot 212023 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A review of the customer feedback database indicates that this is a rare occurrence with this customer being the only customer to provide this type of feedback against the mv0413-0006 product in the past 12 months.H3 other text : see h10.

• Brand Name: BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 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: 13588573
• MDR Text Key: 287596970
• Report Number: 2243072-2022-00265
• 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: 04/04/2022

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 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