BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-CLIK

    MDR report key: 11835 · Received March 2, 1994

    Report

    Report Number
    MW1000954
    Event Type
    Malfunction
    Date Received
    March 2, 1994
    Date of Event
    March 1, 1994
    Report Date
    March 2, 1994
    Manufacturer
    RYAN MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THERE WAS LEAKING OF SOLUTION FROM AROUND THE "HAT" OF THE NEEDLE ADAPTOR. PT WAS ASKED TO SAVE A NEEDLE FOR EXAM SHOULD THIS HAPPEN AGAIN. THE PROBLEM OCCURS AFTER 4-5 HRS OF INFUSION AND THE THREADED CONNECTION TO THE TUBING SEEMS TO BE THE PROBLEM. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T-CLIK PROTECTED-NEEDLE ADAPTOR FPA RYAN MEDICAL, INC. K015F

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR THERAPY AT HOME VIA AVI PUMP (3M).| 2/11/94-RECEIVED TOTAL PARENTERAL NUTRITION