BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBING FREEDOM60 SYR INF

    MDR report key: 12475286 · Received September 14, 2021

    Report

    Report Number
    MW5103949
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    March 29, 2021
    Report Date
    March 30, 2021
    Manufacturer
    REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HAD INBOUND CALL FROM MD OFFICE. SHE REQUESTED THAT (B)(6) CONTACTS NURSING TO HAVE A NURSE GO OUT A SECOND TIME FOR TEACH AND TRAIN OF HIZENTRA ADMINISTRATION. (B)(6) INFORMED US THAT PATIENT EXPERIENCED TUBING LEAKAGE AND PARENTS OF PATIENT WOULD BENEFIT FROM ANOTHER NURSE VISIT PRODUCT COMPLAINT. ADDITIONALLY, PATIENT DEVELOPED A HEMATOMA FOLLOWING THEIR LAST INFUSION. HIZENTRA FIRST SHIPPED TO ARRIVE ON 12/18/2020, EXACT START DATE UNKNOWN. DURATION, ONSET AND RESOLUTION OF PRODUCT COMPLAINT OR ADVERSE REACTION CURRENTLY UNKNOWN. NO OTHER INFORMATION AVAILABLE. UNKNOWN IF PATIENT COMPLETED INFUSION . UNKNOWN IF TUBING IS BEING REPLACED. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368994 TUBING FREEDOM60 SYR INF PUMP, INFUSION FRN REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS #F120

    Patients

    Seq Age Sex Outcome Treatment
    1 25 MO