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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON EMERALD SYRINGE 5ML 24X1 AN

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BECTON DICKINSON EMERALD SYRINGE 5ML 24X1 AN Back to Search Results
Catalog Number 307757
Device Problem Packaging Problem (3007)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/24/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is not registered with the fda. (b)(4). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that emerald syringe 5ml 24x1 an had no cap on the needle which caused the technician to get a needle stick injury. This occurred on 2 occasions before use. The following information was provided by the initial reporter: there was no cap on needle in packed emerald 5ml syringe with needle. When ot technician taken it for use he got needle stick injury because of no cap on needle.
 
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Brand NameEMERALD SYRINGE 5ML 24X1 AN
Type of DeviceSYRINGE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10525396
MDR Text Key208790263
Report Number2243072-2020-01411
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number307757
Device Lot Number0107872
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/16/2020
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: 09/11/2020 Patient Sequence Number: 1
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