BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFSITE NEEDLELESS IV ACCESS PIN

    MDR report key: 14277 · Received April 12, 1994

    Report

    Report Number
    14277
    Event Type
    Malfunction
    Date Received
    April 12, 1994
    Date of Event
    April 11, 1994
    Report Date
    April 12, 1994
    Manufacturer
    BURRON MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEAK DISCOVERED AT UPPER Y SITE. IV FLUID LEAKING FROM ACCESS PIN. NURSE REMOVED ACCESS PIN AND REPLACED WITH NEW ACCESS PIN. AFTER EXAMINATION OF LEAKING ACCESS PIN, IT WAS DETERMINED PIN WAS ABSENT. PIN NOT RECOVERED. PERIPHERAL IV CATHETER SIZE 18 GA. ACCESS PIN IS 15 GA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFSITE NEEDLELESS IV ACCESS PIN ACCESS PIN FPA BURRON MEDICAL, INC. AP 2500

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other