BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SCIG 26G 6MM HIGH FLO

    MDR report key: 14488353 · Received May 23, 2022

    Report

    Report Number
    MW5109852
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    May 13, 2022
    Report Date
    May 13, 2022
    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
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT MOTHER CALLED TO REPORT PT INFUSION IS LEAKING AT NEEDLE SITE, UNSURE IF DUE TO NEEDLE SET OR IF TUBING IS TOO FAST. PT IS SITTING STILL; NEEDLE IS IN ALL THE WAY. I SUGGESTED TO REINSERT A NEW NEEDLE TO SEE IF THIS WOULD HELP. PT'S MOTHER WILL ATTEMPT AND CALL BACK IF STILL HAVING LEAKING ISSUE. NO OTHER INFORMATION KNOWN. PATIENT DID NOT MISS A DOSE OR REPORT ANY ADVERSE EVENTS. PATIENT DOES NOT HAVE THE DETECTIVE PRODUCT ON HAND. INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150525 IV SCIG 26G 6MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male CUVITRU 20% 1GM/5ML, MFR: BAXALTA