BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV SCIG 26G 9MM HIGH FLO

    MDR report key: 12049697 · Received June 22, 2021

    Report

    Report Number
    MW5102028
    Event Type
    Injury
    Date Received
    June 22, 2021
    Report Date
    June 15, 2021
    Manufacturer
    REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS PT REQUESTED TO HAVE 6MM NEEDLE SET AS "KNOTS" HAVE BEEN MORE OF AN ISSUE WITH THE USE OF THE 9MM NEEDLE SET; NO FURTHER INFO. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935753 IV SCIG 26G 9MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1