BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-NECK CATHETER

    MDR report key: 2088446 · Received May 4, 2011

    Report

    Report Number
    1450420-2011-00002
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MEDIGROUP INC
    Product Code
    FJS
    PMA / PMN Number
    K970159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: THE CATHETER WAS DECONTAMINATED AND VISUALLY INSPECTED. THE DISTAL CUFF WAS MISSING, AND THE PROXIMAL CUFF WAS ABLE TO BE MOVED ON THE TUBING. VISUAL INSPECTION SHOWED THAT THE ADHESIVE RESIDUE WAS THIN, AND THAT APPARENTLY NOT ENOUGH ADHESIVE HAD BEEN USED, ESPECIALLY ON THE PROXIMAL EDGE OF THE CUFF. SIX OTHER CATHETERS OF THE SAME LOT NUMBER WERE TESTED BY INSERTING A CATHETER STYLETTE INTO THE CATHETER TUBING, AND FORCING THE CUFF IMPLANTER TOOL AGAINST THE GLUE BONDS OF THE CUFFS. ALL 12 CUFFS REMAINED FIRMLY ADHERED TO THE TUBING.

    Description of Event or Problem · 1

    WHILE A PERITONEAL DIALYSIS CATHETER WAS BEING IMPLANTED LAPAROSCOPICALLY BY A SURGEON IN A PT WITH END STAGE RENAL DISEASE, THE CUFF SEPARATED FROM THE CATHETER. THE SURGEON REMOVED THE PARTIALLY IMPLANTED CATHETER AND REPLACED IT WITH ANOTHER CATHETER. DIALYSIS WAS ACCOMPLISHED; PT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX-NECK CATHETER FJS PERITONEAL DIALYSIS CATHETER FJS MEDIGROUP INC CF-5260 V-3365

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention