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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE

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BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE Back to Search Results
Catalog Number 309050
Device Problem Fluid Leak (1250)
Patient Problem Exposure to Body Fluids (1745)
Event Date 02/24/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter phone#: (b)(6). 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 during use of the bd discardit¿ ii syringe ¿during drug or blood aspiration there is significant leakage to the space between barrel and plunger, no precise syringe calibration. Health care worker was exposed to blood however personal protective equipment worn, no direct contact with skin. ¿ there was no report of injury or medical intervention.
 
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Brand NameBD DISCARDIT¿ II SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7323592
MDR Text Key101994997
Report Number3002682307-2018-00061
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeLO
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number309050
Device Lot Number1709187
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/08/2018 Patient Sequence Number: 1
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