BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML L/L NO NEEDLE

    MDR report key: 8595619 · Received May 8, 2019

    Report

    Report Number
    MW5086475
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 22, 2019
    Report Date
    April 22, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL SPOKE WITH PT REGARDING INFUSION ISSUES. PT STATES HE IS TRYING TO DRAW UP MEDICATION INTO THE SYRINGE BUT NOTHING IS COMING OUT. HE HAS CHANGED THE MIN SPIKE BUT GETTING SAME RESULTS. I ASKED TO UNSCREW THE SYRINGE FROM THE NEEDLE SPIKE, DRAW AIR INTO THE SYRINGE, THEN INJECT THAT INTO VIAL THROUGH, MINI SPIKE. PT UNSCREWED THE SYRINGE BUT STATES HE IS NOT ABLE TO DRAW AIR INTO THE SYRINGE, ADVISED TO USE A DIFFERENT SYRINGE THAT RESOLVED THE ISSUE. REPORTED TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386630 SYRINGE 60ML L/L NO NEEDLE SYRINGE, PISTON FMF BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR