BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE IRRIGATION TRAY

    MDR report key: 16237 · Received September 19, 1994

    Report

    Report Number
    MW1003426
    Event Type
    Malfunction
    Date Received
    September 19, 1994
    Report Date
    September 16, 1994
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EYN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SYRINGE TIP OF THE 60 ML PISTON SYRINGE ON THE TRAY IS TOO SMALL FOR IRRIGATING. IT DOES NOT GIVE A GOOD SEAL ESPECIALLY IN THREE-WAY FOLEY IRRIGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE IRRIGATION TRAY EYN MEDLINE INDUSTRIES, INC. 4F1013

    Patients

    Seq Age Sex Outcome Treatment
    1 *