BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-NECK CATHETER

    MDR report key: 886896 · Received July 26, 2007

    Report

    Report Number
    1450420-2007-00002
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    June 1, 2007
    Report Date
    July 18, 2007
    Manufacturer
    MEDIGROUP INC.
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CANNOT DETERMINE FROM THE INFORMATION PROVIDED WHICH CAME FIRST, THE LEAK OR THE PERITONITIS. NOR CAN WE DETERMINE WHAT CAUSED THE CRACK. POTENTIAL CAUSES COULD BE: DURING MANUFACTURING A BLUNT-TIPPED SCISSORS IS USED TO TRIM THE CUFF, BUT SINCE THE CRACK OCCURRED EXTERNALLY, IT IS DOUBTFUL THAT THE TRIMMING PROCESS CAUSED THE CRACK SINCE THE CUFF AREA IS ON THE INTERNAL PORTION OF THE CATHETER; HARD CLAMPING OF THE CATHETER EXTERNALLY; HOWEVER, THE HOSPITAL STATES THEY DO NOT DO THAT; ACCIDENTAL NICKING OF THE CATHETER WITH SCISSORS DURING DRESSING CHANGES; ACCIDENTAL NICKING OF THE CATHETER DURING IMPLANTATION; SHARP OR REPEATED CREASING (FOLDING) OF THE CATHETER AT THE SAME LOCATION AS PART OF "SECURING" THE CATHETER TO THE PATIENT'S ABDOMEN. FURTHERMORE, THE FACT THAT WE RECEIVED A 24CM EXTERNAL PORTION OF THE CATHETER INDICATES THAT THE SUBCUTANEOUS CUFF WAS PLACED VERY CLOSE TO THE EXIT SITE. THIS MAY, IN TURN, INDICATE THAT THE RECTUS CUFF WAS NOT IN THE RECTUS, AND THIS IS WHAT CAUSED THE LEAK. REASONS FOR THAT ARE BEYOND THE SCOPE OF THIS INVESTIGATION. FROM THE CATHETER SEGMENT RECEIVED, WE ARE UNABLE TO DOCUMENT EXACTLY WHAT HAPPENED OR WHY. A REVIEW OF THE COMPLAINT HISTORY OF THE CATHETER PRODUCT FAMILY INDICATES THAT THIS IS THE FIRST COMPLAINT FOR THIS PRODUCT AND THIS DEFECT MODE SINCE THE INTRODUCTION ON THE CF-5242 INTO THE MARKETPLACE IN 2005. BASED ON THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, THERE IS NO INDICATION THAT THIS MANUFACTURING LOT NUMBER IS SUSPECT OR MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASE ON THE COMPLAINT HISTORY REVIEW, THERE IS NO EVIDENCE OF AN EMERGING TREND OF DEFECTS FOR THIS PRODUCT.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS CATHETER WAS IMPLANTED IN A PATIENT IN A FOREIGN COUNTRY IN 2007, AND IT WAS USED SUCCESSFULLY FOR 2 1/2 MONTHS. PERITONITIS, AN INFECTION OF THE PERITONEUM, WAS DISCOVERED TWO MONTHS LATER. THE CATHETER WAS DISCOVERED TO BE LEAKING ONE MONTH LATER, DUE TO A HOLE OR CRACK IN THE CATHETER TUBING NEAR THE EXIT-SITE, AND THE CATHETER WAS REMOVED. A NEW CATHETER WAS IMPLANTED FOUR DAYS LATER. PATIENT IS "OK" PER REPORT TO MANUFACTURER. PERITONITIS, AN INFECTION OF THE PERITONEUM CAUSED BY VARIOUS ORGANISMS, MOST COMMONLY OCCURS DUE TO PATIENT AND/OR ATTENDANT ERROR IN NOT FOLLOWING STANDARD ASCEPTIC PERITONEAL DIALYSIS PROTOCOL. IT ALSO CAN OCCUR IN THE EVENT OF FLUID LEAKS. THE STANDARD PROTOCOL TO TREAT PERITONITIS IS TO AGGRESSIVELY TREAT THE INFECTION WITH ANTIBIOTICS AND/OR REMOVE THE CATHETER AND CONTINUE THE ANTIBIOTIC TREATMENT. AFTER THE INFECTION HAS CLEARED (10-20 DAYS), A NEW PD CATHETER CAN BE IMPLANTED. SINCE THE PATIENT RECEIVED A NEW CATHETER ON THE SAME DAY, IT CAN BE INFERRED THAT THE INFECTION WAS CLEARED OR REDUCED TO AN ACCEPTABLE POINT. SINCE ONLY 4 DAYS HAD PASSED, IT APPEARS THAT THE PERITONITIS WAS DETECTED EARLY AND THE TREATMENT WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX-NECK CATHETER PERITONEAL DIALYSIS CATHETER FJS MEDIGROUP INC. CF-5242 V-3201

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention