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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL BNS PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL BNS PISTON SYRINGE Back to Search Results
Catalog Number 301027
Device Problems Leak/Splash (1354); Volume Accuracy Problem (1675); Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
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 syringe 5ml ll bns experienced 77 cases of scale marking issues, 18 cases of damaged/deformed stopper, and 18 cases of molding defect -sharp protrusions. The following information was provided by the initial reporter: material no. : 301027, batch no. : 0198845. Material was rejected during production process due the following conditions: 77 pieces were found with printing defects, 18 pieces were found with deformation and flash.
 
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Brand NameSYRINGE 5ML LL BNS
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 Key11952851
MDR Text Key267240653
Report Number1213809-2021-00406
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
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 06/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301027
Device Lot Number0198845
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2020
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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