BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 3946116 · Received June 18, 2014

    Report

    Report Number
    3946116
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    THESE SYRINGES BEING USED FOR BLOOD DRAWS, WERE NOTED ON MORE THAN 10 OCCASIONS TO ASPIRATE AIR INTO THE BLOOD SAMPLES WHILE PULLING THE PLUNGER BACK AND TO LEAK SAMPLE WHILE PUSHING THE PLUNGER CREATING POSITIVE PRESSURE WITHIN THE SYRINGE. THE LEAK OCCURS ON THE SYRINGE BARREL WHERE A THIN CUT APPEARS AT APPROXIMATELY 0.5 ML AWAY FROM THE LUER-LOK CONNECTOR. THIS CUT, WHICH SO FAR HAS ONLY BEEN FOUND ON THE DOCUMENTED LOT, EXTENDS AROUND THE DIAMETER OF THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356903 BD LUER-LOK SYRINGE, PISTON FMF BECTON DICKINSON * 4052473 08

    Patients

    Seq Age Sex Outcome Treatment
    1 *