BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50-60ML L/L NO NEEDLE

    MDR report key: 17661229 · Received August 30, 2023

    Report

    Report Number
    MW5145097
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Report Date
    August 25, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS. PATIENT'S CAREGIVER REPORTED THERE WAS A CHANGE IN THE "1X1" 50 ML SYRINGES SINCE IT WAS NO FITTING ANYMORE IN THE PUMP IN ORDER TO PUSH THE MEDICATION THROUGH. HE WAS NOT ABLE TO INFUSE THE MEDICATION BECAUSE IT HAD TO BE THROWN OUT. UNKNOWN IF PT MISSED A DOSE OR EXPERIENCED AN ADVERSE EVENT. UNKNOWN IF PATIENT HAS DEFECTIVE DEVICE ON HAND FOR POSSIBLE RETURN. UNKNOWN IF PROVIDER IS AWARE. NO FURTHER INFORMATION. REPORTED TO CVS/CAREMARK BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182978 SYRINGE 50-60ML L/L NO NEEDLE SYRINGE, PISTON FMF BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 Male