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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP PISTON SYRINGE Back to Search Results
Catalog Number 302995
Device Problem Crack (1135)
Patient Problem Exposure to Body Fluids (1745)
Event Date 01/10/2019
Event Type  Injury  
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 syringe luer-lok¿ tip filled with bupivacaine "sprayed the nurse practitioner in the eyes" during a lap chole due to a crack "along the length of the shaft".
 
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Brand NameBD SYRINGE LUER-LOK TIP
Type of DevicePISTON SYRINGE
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
8015652341
MDR Report Key8317992
MDR Text Key135521057
Report Number1213809-2019-00158
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 distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number302995
Device Lot Number8150882
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 Received01/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2018
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: 02/07/2019 Patient Sequence Number: 1
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