BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX-NECK PERITONEAL INFANT CATHETER

    MDR report key: 2362867 · Received December 1, 2011

    Report

    Report Number
    MW5023341
    Event Type
    Injury
    Date Received
    December 1, 2011
    Date of Event
    November 29, 2011
    Report Date
    December 1, 2011
    Manufacturer
    MEDIGROUP INC.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFANT ON PERITONEAL DIALYSIS HAD CATHETER PLACED ON (B)(6) 2011, PARENTS NOTED HOLE IN CATHETER (B)(6) 2011 AND BROUGHT PATIENT TO CLINIC WHERE DEFECT IN CATHETER WAS NOTED. THIS WAS WHILE HE WAS UNDER TREATMENT FOR PERITONITIS. CATHETER WAS CUT PROXIMAL TO THE DEFECT AND NEW ADAPTER PLACED, ANTIBIOTICS GIVEN. THIS IS THE SECOND HOLE IN THIS CATHETER WHICH IS EXTREMELY FLEXIBLE AND KINKS FREQUENTLY - MULTIPLE TIMES WITH EACH DIALYSIS TREATMENT. THE FIRST HOLE WAS NOTED (B)(6) 2011 WITH AN EPISODE OF PERITONITIS. HE WILL REQUIRE SURGERY TO REPLACE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX-NECK PERITONEAL INFANT CATHETER PERITONEAL CATHETER, 2 CUFF, COIL FJS MEDIGROUP INC. CF 4430

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Other| S