BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING FREEDOM 60 IV SET

    MDR report key: 12657665 · Received October 18, 2021

    Report

    Report Number
    MW5104694
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    July 1, 2021
    Report Date
    August 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

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM PATIENT COMPLAINS OF LEAKAGE WITH FASTER FLOW - WILL CHANGE TUBING FROM FREEDOM 420 TO FREEDOM 275. PATIENT HAS NO OTHER CONCERNS. UNKNOWN IF PATIENT HAD ADVERSE EVENT. UNKNOWN IF PATIENT STILL HAS TUBING ON HAND. INDICATION: SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN G [IGG] SUB CLASSES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550198 TUBING FREEDOM 60 IV SET PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS F420

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR