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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 309648
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: three photos and three loose 1ml luer-lock syringes (p/n 309648) were received. The samples were visually evaluated. Each syringe was found to have no print present on the barrel which was non-conforming per product specification. All defective samples should be returned for further evaluation. Production records were reviewed as part of this investigation with several instances of "marker jams" including an ink spill that would require the technician to fully clean the marker. A process technician was interviewed and it was stated that a clogged ink manifold can be one of the top contributors towards an ink spill. Potential root cause for the missing print defect is associated with the marking process. It is possible that a clogged ink manifold caused the print to not be properly applied to the printing pad, in turn not printing on the barrel. This series of events would contribute to the condition observed. These conditions are occurring at/below their expected frequency. Therefore, no corrective action is required at this time. Batch #1127509 is considered in compliance with our product specification requirements. Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
 
Event Description
It was reported when using the bd luer-lok¿ syringes there was scale markings missing. This event occurred 917 times. The following information was provided by the initial reporter. The customer stated: there were "syringes without graduations. ".
 
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Brand NameBD LUER-LOK SYRINGE
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 Key12405407
MDR Text Key269572305
Report Number1213809-2021-00607
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K941562
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
Report Date 08/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309648
Device Lot Number1127509
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2021
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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