BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING FREEDOM 60 SYR INF

    MDR report key: 13061847 · Received December 21, 2021

    Report

    Report Number
    MW5106229
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    December 2, 2021
    Report Date
    December 2, 2021
    Manufacturer
    REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
    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

    INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. SPONTANEOUS CALL PATIENT CALLED REPORTING THAT THEIR F120 FREEDOM TUBING WAS DEFECTIVE AND LEAKED OUT ABOUT 10 GM OF THE MEDICATION. PATIENT IS CONTINUING ON INFUSION WITH F180 FREEDOM TUBING WITH THE REMAINDER. NO SIDE EFFECT REPORTED FROM THE PARTIAL DOSE. UNKNOWN IF PRESCRIBER IS AWARE. UNKNOWN IF PATIENT HAS DEFECTIVE PRODUCT ON HAND FOR RETURN FOR INSPECTION. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948338 TUBING FREEDOM 60 SYR INF PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS F120

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male