BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 19816457 · Received July 24, 2024

    Report

    Report Number
    9610711-2024-00188
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 1, 2024
    Report Date
    April 11, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K233411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND DIDN'T FIND SIMILAR COMPLAINTS ON THE LOT 9132239. B3: ESTIMATED DATE.

    Additional Manufacturer Narrative · 0

    IN SEPTEMBER, WE RECEIVED ONE SEALED SAMPLE. AT VISUAL EXAMINATION, WE SAW A HAIR IN THE PRIMARY PACKAGING. THIS SAMPLE WAS SENT TO OUR HUNGARIAN SITE WHICH PACKAGED THIS PRODUCT. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND DIDN'T FIND SIMILAR COMPLAINT ON THE LOT 9132239. CHECKING QUALITY DATABASE REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED PROBLEM. OUR HUNGARIAN SITE PERFORMED ITS INVESTIGATION: POTENTIAL ROOT CAUSES IDENTIFIED: - 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. ACTION(S): - 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." IN ADDITION OUR SUPPLIER, WHO SENDS THE INTERMEDIATE PRODUCT TO OUR HUNGARIAN SITE, HAS RE-SENSITIZED PRODUCTION OPERATORS ABOUT "HAIR PRESENCE" IN NOVEMBER 2024 AND ABOUT A GOOD MANUFACTURING PRACTICE IN MAY 2024.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THERE WAS A PRESENCE OF FOREIGN BODY, A HAIR OR WIRE INSIDE THE STERILE POUCH.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THERE WAS A PRESENCE OF FOREIGN BODY, A HAIR OR WIRE INSIDE THE STERILE POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343237 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9132239_AA61121002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown