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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP PISTON SYRINGE Back to Search Results
Catalog Number 309657
Device Problem Particulates (1451)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2018
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 with the use of the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip there was an issue with gooey, milky substance on the tip of syringe.
 
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Brand NameBD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD 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
8015652845
MDR Report Key8223842
MDR Text Key132373025
Report Number1213809-2018-00986
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309657
Device Lot Number8244745
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 Received12/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2018
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: 01/07/2019 Patient Sequence Number: 1
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