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U.S. Department of Health and Human Services

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

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BECTON DICKINSON, S.A. BD EMERALD¿ SYRINGE Back to Search Results
Catalog Number 307736
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem Exposure to Body Fluids (1745)
Event Date 06/14/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. (b)(6). Three potential lot numbers were provided for this incident. The information for each lot number is as follows:  medical device lot #: 1709373, medical device expiration date: 2022-08-31, device manufacture date: 2017-09-21, medical device lot #: 1702394, medical device expiration date: 2022-01-31, device manufacture date: 2017-02-13, medical device lot #: 1801388, medical device expiration date: 2022-12-31, device manufacture date: 2018-01-30. (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 that the "luer slip adapter broke" on a 10 ml bd emerald¿ syringe while taking blood from a patient resulting in blood splashing onto a nurse's face. The nurse contacted occupational health and was advised "no bloods needed to be taken. " there was no additional medical intervention was reported.
 
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Brand NameBD EMERALD¿ 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 Key7659574
MDR Text Key113061747
Report Number3002682307-2018-00157
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number307736
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/03/2018 Patient Sequence Number: 1
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