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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD LUER-LOK SYRINGE, PISTON

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BECTON, DICKINSON AND COMPANY BD LUER-LOK SYRINGE, PISTON Back to Search Results
Model Number 309653
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 04/08/2019
Event Type  malfunction  
Event Description
We found four empty syringe wrappers (conjoined) that did not contain the syringe packaged in the box. The wrappers still hold air so they have not been opened. Although this is not a contamination issue as was reported by our system-affiliate hospital in medwatch 2402140000-2019-8001 (describes finding several 60cc syringes that contained small white particles inside the syringes). This does seem to point to the continued quality control issues.
 
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Brand NameBD LUER-LOK
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
one becton drive
franklin lakes NJ 07417
MDR Report Key8513543
MDR Text Key141910020
Report Number8513543
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309653
Device Catalogue Number309653
Device Lot Number8360839
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/09/2019
Event Location Hospital
Date Report to Manufacturer04/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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