BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENDALL DOVER

    MDR report key: 732977 · Received June 27, 2006

    Report

    Report Number
    1282497-2006-00029
    Event Type
    Other
    Date Received
    June 27, 2006
    Date of Event
    June 11, 2006
    Report Date
    June 22, 2006
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS BEING RETURNED FOR EVALUATION. WITHOUT A SAMPLE, IT IS DIFFICULT TO CONFIRM THE REPORTED DEFECT. FURTHERMORE, A VALID LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. KENDALL HEALTHCARE IS CONTINUALLY IMPROVING OUR PRODUCTS AND PROCESSES TO PROVIDE OUR CUSTOMERS WITH THE HIGHEST QUALITY PRODUCTS. THEREFORE, WE HAVE FOUND THAT ONE POTENTIAL ROOT CAUSE FOR THIS DEFECT COULD BE AN EMBEDDED PARTICLE OF REMAINING SILICONE FROM THE MOLDING PROCESS. AS A RESULT, PREVENTATIVE ACTIONS ARE BEING INITIATED INCLUDING IMPROVEMENTS TO THE MOLD CLEANING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON JUNE 22, 2006, THAT A CUSTOMER HAD A PROBLEM WITH A FOLEY CATHETER. THE CUSTOMER STATED THAT RIGHT AFTER THEY STARTED TO USE THE CATHETER THE BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL DOVER DOVER SILVER CATHETER 22FR/5CC EZL TYCO HEALTHCARE/KENDALL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN