BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOFRIC ELLE

    MDR report key: 22951091 · Received September 3, 2025

    Report

    Report Number
    3009632672-2025-00028
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 3, 2025
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    EZD
    UDI-DI
    07333387024202
    PMA / PMN Number
    K211212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEWED IMAGE SENT WITH THE COMPLAINT SHOWS THAT THE FUNNEL HAS NOT BEEN MOUNTED CORRECTLY ON THE TUBE. TWO COMPLAINTS WERE REGISTERED PREVIOUSLY TO THIS ONE, REGARDING THE SAME PROBLEM (CATHETER DETACHING FROM FUNNEL). THESE COMPLAINTS WERE FROM UK AND SWEDEN. BATCH DOCUMENTATION AND PRODUCTION DATA HAVE BEEN REVIEWED AND NO RELEVANT PROBLEMS OR DEVIATIONS WERE REGISTERED. EXAMINATION OF THE RETURNED PRODUCT SAMPLES (150) SHOS NO DEFECTS OR DEVIATIONS. MEASUREMENTS FROM THE SUPPLIER'S PEAK TENSILE FORCE TEST SHOW RESULTS WITHIN SPECIFICATIONS FOR SAMPLE FROM THE SAME RAW CATHETER LOT 740625. 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 RAW CATHETER LOT 760787. INVESTIGATION BY THE SUPPLIER CONCLUDED THAT A LIMITED NUMBER OF CATHETERS WERE INCORRECTLY ASSEMBLED IN THIS SPECIFIC LOT. THE MANUFACTURER OF THE EQUIPMENT HAS BEEN ON SITE AND ADJUSTED THE GLUE APPLICATION, AND THE GLUE-RELATED ISSUES 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 (SDR) HAS BEEN OPENED, AND ALL THREE 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. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ADVERSE EVENT OCCURRED OUTSIDE US, IN UK. A 58-YEAR OLD FEMALE PATIENT WITH A HISTORY OF NEUROGENIC BLADDER AND INTERSTITIAL CYSTITIS REPORTED A MALFUNCTION FOR A STERILE, SINGLE-USE, INTERMITTENT URINARY CATHETER LOFRIC ELLE. THE CATHETER WAS INSERTED AS NORMAL BUT UPON WITHDRAWAL THE CATHETER BROKE. THE CATHETER TUBE CAME OFF THE HANDLE AND WAS LEFT INSIDE THE PATIENT'S URETHRA. PATIENT MANAGE TO RETRIEVE THE CATHETER TUBE. THERE WAS NO HARM OR HEALTH IMPACT TO THE PATIENT. PATIENT HASN'T HAD ANY PROBLEMS WITH ANY OTHER CATHETERS IN THE SAME LOT BUT DECIDED TO RETURN THE REST OF THE PRODUCTS IN THIS LOT IN CASE MORE ARE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733805 LOFRIC ELLE CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE 41812 666741 07333387024202

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other