BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SCIG 26G 12MM HIGH FLO

    MDR report key: 21977888 · Received May 7, 2025

    Report

    Report Number
    MW5170051
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Report Date
    May 2, 2025
    Manufacturer
    REPRO MED SYSTEMS, INC. / KORU MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS ONE OF HER NEEDLES WAS DEFECTIVE. THE NEEDLE WAS FLAT AND SHE WAS UNABLE TO INSERT IT INTO HER THIGH. UNKNOWN IF PATIENT MISSED DOSE. NO FURTHER INFORMATION PROVIDED. LOT NUMBER IS NOT AVAILABLE. UNKNOWN IF PRODUCT ON HAND FOR POSSIBLE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795552 IV SCIG 26G 12MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO MED SYSTEMS, INC. / KORU MEDICAL SYSTEMS, INC. RMS4-2612

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female