BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML L/L NO NEEDLE 9657

    MDR report key: 10118533 · Received June 3, 2020

    Report

    Report Number
    MW5094827
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Report Date
    May 27, 2020
    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

    PATIENT REPORTED THAT SYRINGE WAS LEAKING WHEN SHE INJECTED LAST WEEK. WHERE THE NEEDLE AND SYRINGE MEET. PT STATED RECEIVED MOST OF HER MEDICATION AND SHE NOTICED IT WHEN SHE WAS ALREADY INJECTING HER DOSE AND DIDN'T WANT TO TAKE THE NEEDLE OUT AND ATTACH ANOTHER NEEDLE. PATIENT WANTED US TO BE AWARE OF ISSUE. NO ATTACKS REPORTED. NO ADVERSE EVENTS REPORTED. UNKNOWN IF SYRINGE IS AVAILABLE FOR RETRIEVAL. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY PATIENT/ CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578829 SYRINGE 3ML L/L NO NEEDLE 9657 SYRINGE, PISTON FMF BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1