BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX NECK CLASSIC CATHETER

    MDR report key: 1750115 · Received July 2, 2010

    Report

    Report Number
    MW5016611
    Event Type
    Malfunction
    Date Received
    July 2, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 2, 2010
    Manufacturer
    MEDIGROUP, INC.
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERITONEAL DIALYSIS CATHETER PULLED APART AT CONNECTOR SITE WHILE PATIENT WAS AT HOME. PER PROTOCOL, PATIENT WAS BROUGHT IN FOR TRANSFER SET CHANGE AS WELL AS PLACEMENT OF NEW ADAPTER. ALSO GIVEN VANCOMYCIN 1 GRAM AND CEFEPIME 1 GRAM INTRAPERITONEALLY AND SPECIMEN OF PERITONEAL FLUID WAS SENT FOR CELL COUNT, GRAM STAIN AND CULTURE. ALSO REQUIRED ORAL ANTIBIOTIC THERAPY AS ADDITIONAL PROPHYLAXIS AGAINST PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX NECK CLASSIC CATHETER PERITONEAL DIALYSIS CATHETER FJS MEDIGROUP, INC. CF-5260

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR