BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SCIG 26G 12MM HIGH FLO

    MDR report key: 22337162 · Received June 25, 2025

    Report

    Report Number
    MW5171913
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Report Date
    June 23, 2025
    Manufacturer
    REPRO MED SYSTEMS, INC. / KORU MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT REPORTS NEEDLES ARE POPPING OUT BEFORE INFUSION BEGINS AND THAT LONGER NEEDLE SETS AND TEGADERM DID NOT HELP. PT REPORTS THIS HAS BEEN GOING ON FOR A FEW YEARS BUT IS GETTING MUCH WORSE RECENTLY. THE TEGADERM IS NOT STICKING BECAUSE OF "SWEATING". PT REPORTS SOME LEAKAGE AS WELL. UNKNOWN IF LEAKAGE IS DUE TO NEEDLES OR HIZENTRA. PT IS 235 LB SO 12MM NEEDLE SET IS APPROPRIATE FOR WEIGHT AND SHE TRIED LONGER 14MM NEEDLE SET AND THAT DID NOT HELP. CURRENTLY SHE IS HOLDING THE SITES IN PLACE WITH HER HANDS DURING THE ENTIRE INFUSION. PT CONFIRMS STICKING NEEDLES IN AT 90 DEGREES; SHE INFUSES IN OUTER THIGHS, ROTATES SITES, AVOIDS SCAR TISSUE. UNKNOWN IF THE PATIENT MISSED A DOSE OR EXPERIENCED AN ADVERSE EVENT AS A RESULT OF THE DEFECTIVE PRODUCTS. UNKNOWN IF THE PT HAS THE DEFECTIVE PRODUCTS ON HAND FOR POSSIBLE RETURN TO THE MANUFACTURER. NO FURTHER INFORMATION IS KNOWN. INDICATION: MYASTHENIA GRAVIS WITHOUT (ACUTE) EXACERBATION AND NONFAMILIAL HYPOGAMMAGLOBULINEMIA. HIZENTRA LOT NUMBER PROVIDED BY (B)(6) PATIENT RECORD. UNKNOWN NUMBER OF VIALS AFFECTED. THE PRODUCT WAS ADMINISTERED. UNKNOWN IF PRODUCT IS AVAILABLE TO RETURN. UNKNOWN IF PATIENT HAS ANY PHOTOS. PATIENT'S CONTACT INFORMATION: (B)(6). REF REPORT: MW5171914.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238753 IV SCIG 26G 12MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO MED SYSTEMS, INC. / KORU MEDICAL SYSTEMS, INC. RMS4-2612

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female HIZENTRA