BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-NECK PERITONEAL DIALYSIS CATHETER

    MDR report key: 2682921 · Received July 26, 2012

    Report

    Report Number
    1450420-2012-00001
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    November 29, 2011
    Report Date
    December 8, 2011
    Manufacturer
    MEDIGROUP INC
    Product Code
    FJS
    PMA / PMN Number
    K031351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD INFANT PERITONEAL DIALYSIS CATHETER PLACED (B)(6) 2011. HOLE WAS DETECTED IN EXTERNAL PORTION OF CATHETER APPROXIMATELY 4 MONTHS LATER. PT HAD PERITONITIS. A SECTION OF TUBING WAS CUT OFF AND ADAPTER RE-STERILIZED AND RE-USED. APPROXIMATELY 7 MONTHS LATER, ANOTHER HOLE WAS DETECTED IN THE EXTERNAL PORTION OF THE TUBING, AND PT HAD PERITONITIS CAUSED BY A DIFFERENT ORGANISM. EXTERNAL TUBING WAS REPAIRED TEMPORARILY UNTIL CATHETER COULD BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX-NECK PERITONEAL DIALYSIS CATHETER FJS PERITONEAL DIALYSIS CATHETER FJS MEDIGROUP INC CF-4230 V-3437

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Required Intervention