BEUDAMED
    FDA Adverse Event Other Summary report: N

    10FR 3CC 2WY BK FOLY-JAPAN

    MDR report key: 652830 · Received December 13, 2005

    Report

    Report Number
    1282497-2005-00031
    Event Type
    Other
    Date Received
    December 13, 2005
    Date of Event
    November 3, 2005
    Report Date
    November 25, 2005
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER GIVEN IN THIS COMPLAINT IS NOT THE ONE THAT THE MANUFACTURER PLANT ASSIGNS FOR THE CATHETERS. THE LOT NUMBER PROVIDED IS ASSIGNED BY INTERNATIONAL AFFILIATE WHEN THE PRODUCT IS PACKAGED, SINCE THE PRODUCT IS SENT OUT FROM THE MANUFACTURER PLANT IN BULK. THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. BASED ON A PREVIOUS COMPLAINT WITH SIMILAR FAILURE MODE, THE POTENTIAL ROOT CAUSE OF THIS DEFECT COULD HAVE BEEN AN EMBEDDED PARTICLE OF REMAINING SILICONE WHICH IS CAUSED DUE TO AN IMPROPER CLEANLINESS TO THE BALLOON MOLD. AFTER A PREVIOUS PROCESS INVESTIGATION WE FOUND AN OPPORTUNITY TO IMPROVE IN THE BALLOON MOLDING PROCESS TO REDUCE AND CONTROL THE BALLOON BURST DEFECT CAUSE BY PARTICLE EMBEDDED OR CONTAMINATION. THE MANUFACTURING TEAM HAS IMPLEMENTED ADDITIONAL PREVENTATIVE MAINTENANCE. MOLDS AND CORE PINS ARE NOW BEING INSPECTED AND CLEANED NIGHTLY DURING THE 3RD SHIFT. THE LOT # IN THIS COMPLAINT WAS PRODUCED BEFORE THIS ACTION. CURRENTLY, A MAIN IMPROVEMENT ACTION IS IN PROGRESS TO PREVENT THE CONTAMINATION OF THE SILICONE BALLOONS. THE NELLCOR TEAM IS WORKING TO DEVELOP A NEW CATHETER CLEANING METHOD TO CLEAN THE MOLDS FOR BETTER RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 2005, THAT A CUSTOMER HAD A PROBLEM WITH A FOLEY CATHETER. THE CUSTOMER ALLEGES THAT THE BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10FR 3CC 2WY BK FOLY-JAPAN SILICONE FOLEY CATHETER 10FR KOD TYCO HEALTHCARE/KENDALL NA 724792

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other