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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE SYRINGE WITH NEEDLE

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 309644
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/26/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 luer-lok¿ syringe with bd precisionglide¿ needle ¿the clinical manager reported that when the bd syringe needle was inserted into vial to draw up medication, the needle separated from the hub and stuck in the rubber stopper of the medication vial. ¿ there was no report of injury or medical intervention.
 
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Brand NameBD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7389147
MDR Text Key104266786
Report Number1213809-2018-00210
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309644
Device Lot Number7210935
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 Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2017
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: 04/02/2018 Patient Sequence Number: 1
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