BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 3946122 · Received July 10, 2014

    Report

    Report Number
    3946122
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BECTON DICKINSON & CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO GIVE AN INJECTION THE CAP AND NEEDLE (NOT REMOVABLE) SEPARATED FROM THE SYRINGE TOGETHER ON 3 NEEDLES. NO PATIENT OR STAFF INJURY OR RISK.======================MANUFACTURER RESPONSE FOR SYRINGE, 1ML 29GX1/2" 7.10.14, B-D (PER SITE REPORTER).======================LEFT VM, NO RESPONSE YET, WILL RETURN IF REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402536 BD SAFETY-LOK SET, ADMINISTRATION, INTRAVASCULAR FMF BECTON DICKINSON & CO. 329464 4063319

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES