BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-NECK CATHETER

    MDR report key: 1674307 · Received April 22, 2010

    Report

    Report Number
    1450420-2010-00001
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    MEDIGROUP INC
    Product Code
    FJS
    PMA / PMN Number
    K071167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RECEIVED AT MEDIGROUP'S FACILITY AND DE-CONTAMINATED ON (B)(6) 2010. VISUAL EXAMINATION OF THE CATHETER INDICATED THAT THERE WERE TWO RESIDUAL BANDS OF ADHESIVE WHERE THE CUFF HAD BEEN. ON (B)(6), THE CATHETER WAS EXAMINED BY THE PRODUCTION AND QUALITY MANAGERS AT THE MANUFACTURING FACILITY. THEIR INVESTIGATION SHOWED THAT PROPER GLUING PROCEDURES WERE FOLLOWED FOR THIS LOT#. A ROOT CAUSE CANNOT BE DETERMINED SINCE THE CUFF ITSELF WAS NOT AVAILABLE FOR REVIEW. A REVIEW OF THE COMPLAINT HISTORY FOR THIS PRODUCT INDICATES THAT THIS IS THE FIRST COMPLAINT FOR THIS PRODUCT AND DEFECT MODE SINCE THE PRODUCT'S INTRODUCTION TO THE MARKETPLACE IN (B)(4) 2007. BASED ON THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, THERE IS NO INDICATION THAT THIS LOT NUMBER IS SUSPECT OR MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE COMPLAINT HISTORY REVIEW, THERE IS NO EVIDENCE OF AN EMERGING TREND OF DEFECTS FOR THIS PRODUCT. DEVICE EVALUATION SUMMARY: THE CATHETER WAS DECONTAMINATED AND VISUALLY INSPECTED. THERE WERE TWO BANDS OF ADHESIVE RESIDUE ON THE CATHETER WHERE THE CUFF HAD BEEN. BECAUSE THE CUFF WAS NOT AVAILABLE FOR REVIEW, THE DEGREE OF ADHESION OF THE CUFF COULD NOT BE CHECKED. A CATHETER WITH THE SAME LOT NUMBER WAS EVALUATED. A STYLETTE WAS INSERTED IN THE CATHETER, AND A CUFF IMPLANTOR FORCED AGAINST THE GLUE BONDS OF THE TWO CUFFS. THE CUFFS REMAINED FIRMLY ADHERED TO THE CATHETER.

    Description of Event or Problem · 1

    WHILE AN UPPER-ABDOMINAL PERITONEAL DIALYSIS CATHETER WAS BEING IMPLANTED BY A SURGEON INTO A PATIENT WITH END STATE RENAL DISEASE, THE CUFF SEPARATED FROM THE CATHETER. THE SURGEON REMOVED THAT CATHETER AND THE CUFF, AND REPLACED IT WITH ANOTHER CATHETER. DIALYSIS WAS ACCOMPLISHED; PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX-NECK CATHETER FJS PERITONEAL DIALYSIS CATHETER FJS MEDIGROUP INC CF-5560 V-3371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention