BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINNTECH

    MDR report key: 19317 · Received June 6, 1994

    Report

    Report Number
    2243621-1994-00115
    Event Type
    Other
    Date Received
    June 6, 1994
    Date of Event
    May 2, 1994
    Report Date
    May 20, 1994
    Manufacturer
    MINNTECH CORP
    Product Code
    FKY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES THAT BLOOD PORT AND DIALYSATE PORT CAPS ARE DIFFICULT TO REMOVE, ONCE IN PLACE. THIS HAS RESULTED IN FORMALDEHYDE SPILLS, CAUSING FORMALDEHYDE REACTION IN CLINIC EMPLOYEE. SYMPTOMS INCLUDE CHEST TIGHTNESS, DRY THROAT, EYE IRRITATION, AND TINGLING SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINNTECH VENTABLE BLOOD PORT CAP FKY MINNTECH CORP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other