BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING FREEDOM 60 SYR INF

    MDR report key: 11076501 · Received December 24, 2020

    Report

    Report Number
    MW5098541
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Report Date
    December 21, 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

    SPONTANEOUS INBOUND CALL FROM PATIENT STATING HER TUBING BROKE DURING HER INFUSION AND SPILLED HER HIZENTRA. SHE USED ANOTHER TUBING & DOSE BUT IS NOW SHORT BOTH FOR HER NEXT INFUSION. NO MISSED DOSE; NO ADVERSE EVENT REPORTED. LOT NUMBER AND EXPIRATION DATE UNKNOWN. UNKNOWN IF DEVICE AVAILABLE FOR RETURN. NO FURTHER INFORMATION. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534976 TUBING FREEDOM 60 SYR INF SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1