BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50-60ML L/L NO NEEDLE

    MDR report key: 22994358 · Received September 8, 2025

    Report

    Report Number
    MW5175713
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Report Date
    September 4, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT'S MOTHER REPORTED SHE MIXED ONE DOSE OF RIASTAP AND FOUND BLACK SPECKS IN SYRINGE. MIXED ANOTHER DOSE THINKING THAT ONE SYRINGE WAS THE ONLY ONE AND ANOTHER SYRINGE ALSO HAD BLACK SPOTS. BOTH DOSES MIXED AND CONCERNED ABOUT SAFETY/STERILITY OF SYRINGES. UNKNOWN IF PATIENT MISSED A DOSE OR EXPERIENCED AN ADVERSE EVENT. UNKNOWN IF DEFECTIVE PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION, DETAILS OR DATES PROVIDED. PATIENT CODE: 4580. DEVICE CODE: 1120. REFERENCE REPORT#: MW5175714.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573641 SYRINGE 50-60ML L/L NO NEEDLE SYRINGE, PISTON FMF BECTON DICKINSON 5154158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male HEPARIN L/L FLUSH SYR (5ML).| LIDOCAINE/PRILOCAINE CRM.| NORMAL SALINE FLUSH (10ML).| SODIUM CHLOR POSIFLUSH (10ML).| STERILE WATER SDV (100ML/VL).