BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING FREEDOM 60 SYR INF

    MDR report key: 10747639 · Received October 27, 2020

    Report

    Report Number
    MW5097482
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Report Date
    October 8, 2020
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT INFORMED THAT MEDICATION GAMUNEX-C DID NOT GO THROUGH THE F180 WHERE HE HAD TO SWITCH TO F900 OR F2400. PATIENT REQUESTING DIFFERENT TUBING. NO FURTHER INFORMATION PROVIDED. NO ADVERSE EFFECTS REPORTED. SPONTANEOUS. LOT NUMBER IS UNAVAILABLE. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209387 TUBING FREEDOM 60 SYR INF SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1