BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOTECH MCFK60

    MDR report key: 74968 · Received February 28, 1997

    Report

    Report Number
    2518902-1997-00006
    Event Type
    Malfunction
    Date Received
    February 28, 1997
    Date of Event
    January 29, 1997
    Report Date
    January 31, 1997
    Manufacturer
    MEDCOMP
    Product Code
    LFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    4/14/97 CO HAS REQUESTED ADDITIONAL INFORMATION FROM THIS FOREIGN DISTRIBUTOR 3 TIMES AND NONE HAS BEEN FORTHCOMING. DUE TO THIS, CO WOULD LIKE TO CLOSE THIS COMPLAINT.

    Description of Event or Problem · 1

    "WHEN THE DR TRY AND GET OUT THE GUIDEWIRE, DURING THE INSERTION OF THE CATHETER, IT HAS BEEN VERY DIFFICULT, AS IF SOME SPIRALS OF THE GUIDEWIRE WERE JAMMED AT THE TOP OF THE NEEDLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOTECH MCFK60 HEMODIALYSIS INSERTION SET AND CATHETER LFK MEDCOMP KF15T M614520

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention