BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE, 10ML/L/L NO NDL

    MDR report key: 9437995 · Received December 6, 2019

    Report

    Report Number
    MW5091529
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 25, 2019
    Report Date
    November 27, 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, MOM REPORTED THAT SHE WAS OUT OF SYRINGES AND TRIED USING A LARGER SYRINGE AND THE SYRINGE DID NOT WORK CORRECTLY. AS A RESULT THE LIQUID SQUIRTED OUT OF THE SYRINGE ONTO THE TABLE AND WAS WASTED. UNK IF PT MISSED A DOSE OR HAD ANY SIDE EFFECTS. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228222 SYRINGE, 10ML/L/L NO NDL SYRINGE, PISTON FMF BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR