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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE Back to Search Results
Catalog Number 301029
Device Problems Volume Accuracy Problem (1675); Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
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 that bd 10ml syringe luer-lok¿ tip experienced 2 cases of scale marking issues, misaligned scale markings, and molding defect -sharp protrusions. The following information was provided by the initial reporter: material no: 301029, batch no: 0064487. Inconsistent step, flash, poor printing, etc.
 
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Brand NameBD 10ML 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11817464
MDR Text Key250398978
Report Number1213809-2021-00316
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 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301029
Device Lot Number0064487
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 Received05/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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