BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV SCIG 26G 9MM HIGH FLO

    MDR report key: 10559689 · Received September 18, 2020

    Report

    Report Number
    MW5096750
    Event Type
    Injury
    Date Received
    September 18, 2020
    Report Date
    August 31, 2020
    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

    INDICATION: SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN G [IGG] SUBCLASSES SPONTANEOUS CALL. PATIENT CALLED IN AND STATED THAT LAST INFUSION NEEDLE SET SOMEHOW MALFUNCTIONED AND ONLY 1 OR 2 SITES WERE INFUSED ON ONE SIDE AND THE PATIENT USUALLY WATCHES TV AND DID NOT NOTICE UNTIL INFUSION WAS COMPLETE. THAT NIGHT THE DISTENTION CAUSED A LOT OF DISCOMFORT AND DIFFICULT TO SLEEP. PT DID NOT MISS A DOSE; UNKNOWN IF NEEDLE SET IS AVAILABLE FOR RETURN; LOT/EXPIRATION UNKNOWN. NO FURTHER INFORMATION KNOWN. NEEDLE SET IS USED TO INFUSE GAMUNEX-C 10% AS ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021717 IV SCIG 26G 9MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS RMS4-2609

    Patients

    Seq Age Sex Outcome Treatment
    1