BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTER SYRINGE FREEDOM60

    MDR report key: 20135496 · Received September 3, 2024

    Report

    Report Number
    MW5159197
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Report Date
    August 23, 2024
    Manufacturer
    KORU MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED CURRENT TRANSFER DEVICE DOES NOT WORK. UNKNOWN IF PT MISSED A DOSE, ADVERSE EVENT EXPERIENCED, AVAILABLE FOR RETURN OR IF MD AWARE. NO FURTHER INFORMATION PROVIDED. PRODUCT LOT NUMB NOT PROVIDED. INDICATION=NONFAMILIAL HYPOGAMMAGLOBULINEMIA, SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN G [IGG] SUBCLASSES, SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN A [IGA]. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711535 ADAPTER SYRINGE FREEDOM60 PUMP, INFUSION FRN KORU MEDICAL SYSTEMS, INC. 348145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female HIZENTRA 20% PFS (1GM TOTAL)