BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 50-60ML L/L NO NEEDL

    MDR report key: 11337416 · Received February 16, 2021

    Report

    Report Number
    MW5099409
    Event Type
    Injury
    Date Received
    February 16, 2021
    Report Date
    February 9, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS THAT SHE HAS BEEN SICK OR HAD AN INFECTION (SYMPTOMS/ FURTHER DETAILS NOT REPORTED). MD IS AWARE. SHE ALSO STATES I HAVE HAD TWO BARREL SYRINGES START LEAKING. I'VE HAD TO TRANSFER THE MEDICINE TO NEW SYRINGES BOTH TIMES. NO MISSED DOSE REPORTED. NO SIDE EFFECTS REPORTED. UNKNOWN IF LEAKY SYRINGES ON HAND FOR RETURN TO THE MANUFACTURER, LOT NOT PROVIDED. REPORTED (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232877 SYRINGE 50-60ML L/L NO NEEDL SYRINGE, PISTON FMF BECTON DICKINSON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1