BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIGROUP

    MDR report key: 1669388 · Received April 23, 2010

    Report

    Report Number
    MW5015686
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    April 16, 2010
    Report Date
    April 23, 2010
    Manufacturer
    MEDIGROUP, INC.
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT IS A HOME PERITONEAL DIALYSIS PATIENT. PATIENT'S CATHETER WAS LEAKING WHERE THE CATHETER CONNECTOR MEETS WITH THE TRANSFER SET. THIS IS THE SECOND INCIDENT THIS PATIENT HAS ENCOUNTERED AND THE THIRD SUCH INCIDENT WITH THESE CATHETERS. ALL THREE OF THESE INCIDENTS WERE REPORTED TO MANUFACTURER. THE FIRST INCIDENT REPORTED AUGUST LAST YEAR, THE SECOND INCIDENT REPORTED DEC 09 WAS GIVEN A VERBAL REPORT THAT WAS CAUSED FROM MISUSE OF EQUIPMENT. (B) (6) 2010 INCIDENT WITH SAME BRAND OF CATHETERS WHERE CATHETER BROKE AT CONNECTOR SITE, THIS IS THE SECOND SUCH INCIDENT WITH THIS BRAND OF CATHETER. APRIL 2010 RECEIVED FOLLOW UP LETTER FROM MANUFACTURER AFTER REQUESTING. DATES OF USE: (B) (6) 2009-(B) (6) 2010 (CURRENTLY USING). DIAGNOSIS OR REASON FOR USE: PERITONEAL DIALYSIS. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIGROUP PERITONEAL DIALYSIS CATHETER CLASSIC ADULT COILED CATHETER FJS MEDIGROUP, INC. CF-5260 V-3329

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other