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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. ".
 
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Brand NameBD SMARTSITE¿ NEEDLE-FREE CONNECTOR
Type of DeviceINTRAVASCULAR 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
0 Patients were 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
Device Catalogue Number2000E-04
Device Lot Number21046258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2021
Was the Report Sent to FDA?
Event Location No Information
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

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