BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SODIUM CHLORIDE 0.9% FLUSH

    MDR report key: 17710497 · Received September 7, 2023

    Report

    Report Number
    MW5145359
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    July 31, 2023
    Report Date
    September 1, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    NGT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT BROKE OUT IN HIVES AT THE END OF HER INFUSION OF IVIG. HIVES SPREAD OUT ALL OVER HER LIMBS, TORSO AND NECK (ASIDE FROM HANDS AND FEET). SHE TOOK ORAL DIPHENHYDRAMINE AND THE REACTION WENT AWAY AFTER ABOUT 2 HOURS. THE REACTION COULD BE ATTRIBUTED TO THE IVIG PRODUCT, SALINE FLUSH OR HEPARIN FLUSH. REFERENCE REPORT #MW5145360.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150109 SODIUM CHLORIDE 0.9% FLUSH SALINE, VASCULAR ACCESS FLUSH NGT MEDLINE INDUSTRIES, LP - NORTHFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other GAMUNEX-C 10%