BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H/S CATHETER SET

    MDR report key: 27260 · Received August 8, 1995

    Report

    Report Number
    27260
    Event Type
    Injury
    Date Received
    August 8, 1995
    Date of Event
    March 3, 1995
    Report Date
    April 26, 1995
    Manufacturer
    ACKARD LABORATORIES, INC.
    Product Code
    LKF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING HYSTEROSALPINOGRAM WHEN CONTRAST WAS INJECTED IT WAS DISCOVERED THAT THE TIP OF THE CATHETER HAD PENETRATED THE VASCULAR SYSTEM OF THE UTERUS. APPROX 10CC'S OF CONTRAST WAS INJECTED. FAMILY'S RADIOLOGISTS ALSO QUESTION WHETHER THE TIP OF THESE CATHETERS SHOULD BE SOFTER I.D. "FLOPPY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H/S CATHETER SET HYSTEROSALPINOGRAPHY CATHETER LKF ACKARD LABORATORIES, INC. 61-3005 5F 3880

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization