BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXXIM MEDICAL

    MDR report key: 225835 · Received June 1, 1999

    Report

    Report Number
    MW1016439
    Event Type
    Malfunction
    Date Received
    June 1, 1999
    Date of Event
    May 23, 1999
    Report Date
    May 24, 1999
    Manufacturer
    MAXXIM MEDICAL, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FLUID INFUSED THROUGH SIDE PORT LEAKS "BAD" THROUGH TOUHY-BORST INTO STERILE SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXXIM MEDICAL Implant TUOHY-BORST INTRODUCER 8.5 F DYB MAXXIM MEDICAL, INC. * 98125165 OR 99025682

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other