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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD SMARTSITE¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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BD SMARTSITE¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2000E-04
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
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 the bd smartsite¿ needle-free connector would not flush with saline due to blockage/occlusion.The following information was provided by the initial reporter: "post iv cannulation nurse connected smart site to cannula, initiated flush but unable to flush with saline via smart site.".
 
Event Description
It was reported that the bd smartsite¿ needle-free connector would not flush with saline due to blockage/occlusion.The following information was provided by the initial reporter: "post iv cannulation nurse connected smart site to cannula, initiated flush but unable to flush with saline via smart site".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-08-26.H6: investigation summary.One 2000e-04 sample was received in open packaging for investigation from lot 21046258.Further information provided by customer indicates that occlusion was identified whilst connected to bd posiflush syringe; however the connecting product in use at the time of the customer's experience was not returned to assist the investigation.A visual inspection of the returned sample did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting the smartsite component to a retained 50ml bd plastipak syringe from stock; no flow restrictions or occlusions were identified.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21046258 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 customer's experience could not be determined as no occlusion or flow restriction was observed during testing of the returned smartsite.Following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion of this nature.Capa 1998036 has been initiated.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston of the smartsite during the assembly process; fluorosilicone is used as a lubricant within the smartsite to ensure the consistent opening of the piston when the smartsite is activated, and an insufficient amount may cause a temporary occlusion.
 
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Brand Name
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12468883
MDR Text Key271319434
Report Number9616066-2021-52034
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2000E-04
Device Lot Number21046258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2021
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2021
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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