BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOFRIC ELLE

    MDR report key: 22685764 · Received August 1, 2025

    Report

    Report Number
    3009632672-2025-00022
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 4, 2025
    Report Date
    August 1, 2025
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    EZD
    PMA / PMN Number
    K211212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH DOCUMENTATION AND PRODUCTION DATA HAVE BEEN REVIEWED AND NO RELEVANT PROBLEMS OR DEVIATIONS WERE REGISTERED. ONE COMPLAINT WAS REGISTERED PREVIOUSLY TO THIS ONE, REGARDING THE SAME PROBLEM (CATHETER DETATCHING FROM FUNNEL). THIS COMPLAINT WAS FROM THE UK. THE COMPLAINTS HAVE CONCERNED DIFFERENT PRODUCT LOTS BUT THE SHARED THE SAME RAW CATHETER LOT. THE PATIENT SENT 5 UNUSED PRODUCTS BACK FROM THE SAME LOT AS THE FAULTY PRODUCT AND 3 UNUSED PRODUCTS FROM ANOTHER LOT. MEASUREMENTS FROM THE SUPPLIER'S PEAK TENSILE FORCE TEST SHOW RESULTS WITHIN SPECIFICATIONS. VISUAL INSPECTION, MANUALLY FUNCTION AND PEAK TENSILE FORCE WAS PERFORMED ON THE RETURNED PRODUCTS AND THE RESULTS WERE APPROVED. RETURNED PRODUCTS WHERE ACCORDING TO SPECIFICATIONS. NO FURTHER SAMPLES FROM THE SAME LOT OR RAW CATHETER LOTS WERE STILL AVAILABLE WITHIN WELLSPECT'S CONTROL FOR TESTING. CONTACT WITH THE SUPPLIER OF THE RAW CATHETER, SHOWED THERE IS AN OPEN NON-CONFORMITY ON THE SAME ISSUE. THIS WAS IDENTIFIED IN WELLSPECT'S PRODUCTION IN JUNE, FOR LOT RAW CATHETER LOT 760787. INVESTIGATION BY THE SUPPLIER CONCLUDED THAT A LIMITED NUMBER OF CATHETERS WERE INCORRECTLY CONSTRUCTED IN THIS SPECIFIC LOT. QUALITY ENGINEER AT SUPPLIER STATES THE INCORRECT CONSTRUCTION IS MOST LIKELY CONNECTED TO A BUILD-UP OF GLUE RESIDUE ON THE CONNECTOR CRADLES. THE MANUFACTURER OF THE EQUIPMENT HAS BEEN ON SITE AND ADJUSTED THE GLUE APPLICATION AND THE ISSUE DECREASED AFTERWARDS. MORE CONTROLS OF THE DEFECT PRODUCTS WILL BE PERFORMED AND FURTHER INVESTIGATION WILL TAKE PLACE. IN ORDER TO DECREASE THE RISK OF INCORRECTLY ASSEMBLED PRODUCTS REACHING CUSTOMERS, THE SUPPLIER WOULD LIKE TO INSTALL A SENSOR TO MEASURE THE LENGTH OF THE CATHETERS INLINE AND THEY WILL GET BACK TO US WHEN THEY HAVE FOUND AN APPROPRIATE SOLUTION FOR THIS. A SUPPLIER DEVIATION REPORT HAS BEEN OPENED AND BOTH COMPLAINTS WERE MANUFACTURED BEFORE THE SDR WAS INITIATED. REFERENCING TO THE ABOVE INVESTIGATION BY THE SUPPLIER WE AGREE THAT THIS IS A PLAUSIBLE ROOT CAUSE FOR THE DESCRIBED PRODUCT PROBLEM. WE WILL CONTINUE TO MONITOR THE SUPPLIERS SUGGESTED IMPROVEMENTS CLOSELY USING THE SDR.

    Description of Event or Problem · 0

    PRODUCT PROBLEM OCCURRED OUTSIDE US, IN SWEDEN. A FEMALE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED A MALFUNCTION FOR THE STERILE, SINGLE-USE, INTERMITTENT URINARY CATHETER LOFRIC ELLE (10CM, CH12). THE CATHETER TUBE CAME APART FROM THE HANDLE WHEN OPENING THE PRODUCT AND FELL INTO THE TOILET BEFORE USE. THERE WAS NO HARM OR HEALTH IMPACT TO THE PATIENT. THE FAULTY CATHETER WAS DISCARDED. THE PATIENT COULD SUCCESSFULLY PERFORM HER CATHETERIZATION USING ANOTHER PRODUCT SHE HAD AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339696 LOFRIC ELLE CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE 41812 664085

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female