BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-SERIES PERITONEAL DIALYSIS CATHETER

    MDR report key: 3855835 · Received May 8, 2014

    Report

    Report Number
    3855835
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDCOMP - MEDICAL COMPONENTS, INC
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD WOMAN WITH END STAGE RENAL DISEASE UNDERWENT LAPAROSCOPIC INSERTION OF CAPD CATHETER USING MEDCOMP CAPD CATHETER. CONNECTOR AND CAP/CLIP WAS APPLIED BUT THAT NIGHT PT PRESENTED TO LOCAL HOSPITAL WITH CLEAR LEAKAGE THROUGH HER DRESSING AND THE CAP WAS FOUND TO BE IN THE DRESSING, HAVING COME DISCONNECTED FROM THE PD CATHETER. PT REQUIRED HOSPITALIZATION FOR PERITONITIS. FDA 3500A REPORT FILED AFTER THE PERITONEAL DIALYSIS CLINIC COMPLAINED TO THE SURGEON ABOUT THE MEDCOMP CONNECTOR FORMING A LOOSE AND UNRELIABLE CONNECTION WITH THE FRESENIUS TRANSFER SETS IN TWO ADDITIONAL PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279119 I-SERIES PERITONEAL DIALYSIS CATHETER 57CM DOUBLE CUFF PERITONEAL CATH LJS MEDCOMP - MEDICAL COMPONENTS, INC MBGP030

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| L