BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 18453986 · Received January 5, 2024

    Report

    Report Number
    9610711-2024-00008
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    December 6, 2023
    Report Date
    June 19, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040126974
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN¿T FIND OTHER COMPLAINT ON THE LOT N°9090710. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. THE HUNGARIAN INVESTIGATION CONCLUDED: THE PRODUCTION PLACE IS A ISO CLASS-VIII CLEAN AREA, IN THIS PRODUCTION AREA EVERYTIME HAVE TO WEAR THE NECCESSARY UNIFORM; MEANS HAVE TO WEAR CLEAN & STERILIZED JACKET AND HAIRNET AND SHOE TOO. IN CASE OF MEN HAVE TO WEAR BEARD COVER. THIS RULE IS ALWAYS FOLLOWED. EVEN SO ACCIDENTALY CAN BE OCCURRENCED TO FALL HAIR INTO THE PACKAGE. ACCIDENTALY HAVE OCCURRENCE TO FALL HAIR INTO THE PACKAGE. THIS IS A MANUAL PACKAGING WITHOUT AUTOMIZED CAMERA OR SENSOR CONTROL, MEANS THAT ONLY HAVE HUMAN RESPONSIBLE TO CONTROL THE WHOLE PRODUCTION PROCESS. NO CAMERA OR SENSOR HAVE INSTALLED TO CHECK THE COMPLETE PACKAGING FOR HAIR OR FOREIGN MATERIAL PRESENCE. NO PLAN TO IMPLEMENT ADDITIONAL PACKAGING CONTROL, DUE TO THE FACT THAT THE PACKAGING IS VERY DIFFICULT TO FILTER OUT BY CAMERA SYSTEM BECAUSE THE PACKAGING IS NOT CONSTANT; THE PACKAGING MATERIAL ARE SHINY; NO POSSIBLE TO SET THE CAMERA FOR THIS, THAT WOULD NOT BE A STABILE SYSTEM. IT'S CONFIRMED THAT SOMETIMES WE RECEIVE THAT RAW MATERIALS FROM OUR SUPPLIERS WITH THIS PHENOMENON, THAT THE HAIR IS ALREADY PART IN THE POUCH. THE AFFECTED MATERIALS HAVE BEEN REJECTED BY US. THIS MATERIALS HAVE ALREADY PACKAGED INTO THE FIRST LEVEL (PRIMARY) PACKAGING, SO IT'S NOT ALLOWED TO OPENED. THE QUALITY ALERT HAVE BEEN ALWAYS SENT TO THE SUPPLIER. BUT NOT EASY TO FILTER OUT ALL POLLUTED RAW MATERIAL FROM THE BATCH BECAUSE THE HAIR IS NOT VISIBLE EASILY THAT IS WHY ACCIDENTALLY SOME AFFECTED PRODUCTS CAN BE ESCAPED TO THE MARKET. THIS IS AN ACCIDENTALLY ISSUE, DURING THE PRODUCTION AND PACKAGING PROCESS, THE HAIR CAN BE GONE INTO THE PACKAGING. SECOND, SUPPLIER RELATED ISSUE, THE RAW MATERIAL HAVE ARRIVED WITH ALREADY POLLUTED BY HAIR. THIRD, HUMAN INATTENTION, THE OPERATORS HAVE NOT DETECTED THE HAIR THEN THE PRODUCT HAVE PACKAGED AND SHIPPED OUT TO THE MARKET. ALL INVOLVED EMPLOYEES HAVE BEEN INFORMED FROM THIS ISSUE, THEY WILL FOCUS TO FILTER OUT THE HAIR INFECTED POUCHES ALL THE TIME AT PRODUCTION ORDER STARTING TO AVOID REOCCURRENCE CLAIMS IN THE FUTURE. CONTINUOUSLY INFORM THE SUPPLIER ABOUT THE AFFECTED LOTS TO IMPROVE THEIR PROCESSES, IF THE RECEIVED LOTS AFFECTED BY HAIR CONTAMINATION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION AN EYELASH WAS WELDED INTO THE INNER STERILE PACKAGING. NO DEFICITS FOR PATIENT OR PROCEDURE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION AN EYELASH WAS WELDED INTO THE INNER STERILE PACKAGING. NO DEFICITS FOR PATIENT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561349 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9090710_AA61081002 03600040126974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown