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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MV0420-0006
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2022
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 212064, medical device expiration date: 01nov2024, device manufacture date: 02nov2021.The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using smartsite¿ vented vial access device there were clogging issues.There was no report of patient impact.The following information was provided by the initial reporter, translated from italian to english: the spike at the coupling breaks, not piercing the rubber of certain drugs.The bayonet fitting does not allow access to the syringe very often, putting the operator at risk.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 02-nov-2022.H6.Investigation summary: four mv0420-0006 samples were received for investigation in sealed packaging; three from lot 212064 and one from lot 212085.From the information provided by the customer it appears that the customer experienced difficulty in piercing the septum of the vial.The details of this feedback were shared with the legal manufacturer of the product, yukon medical llc, for investigation.It was not possible to confirm the exact root cause of the customer's experience in this instance.There were no issues identified during testing of the returned product and it was not possible to identify any manufacturing defects that could have caused or contributed to the customer¿s experience.A review of the production records for lots 212064 and 212085 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note that the spike of the mv0420-0006 vial access device is designed to be inserted at the central circle on the rubber bung of the vial using a vertical force and not by using an angled insertion technique.
 
Event Description
It was reported while using smartsite¿ vented vial access device there were clogging issues.There was no report of patient impact.The following information was provided by the initial reporter, translated from italian to english: the spike at the coupling breaks, not piercing the rubber of certain drugs.The bayonet fitting does not allow access to the syringe very often, putting the operator at risk.
 
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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 Key15764793
MDR Text Key307671266
Report Number2243072-2022-01909
Device Sequence Number1
Product Code FPA
UDI-Device Identifier20885403228480
UDI-Public(01)20885403228480
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
NA
Number of Events Reported1
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 12/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMV0420-0006
Device Lot Number212085
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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