BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

    MDR report key: 22903192 · Received August 27, 2025

    Report

    Report Number
    1018233-2025-07104
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 25, 2025
    Report Date
    May 28, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741039058
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER NOTICED DIFFERENCES IN THE BARDIA® INTERMITTENT CATHETERS UNISEX, 16FR, COUDé (SKU# 802516) MANUFACTURED IN MALAYSIA COMPARED TO THOSE MADE IN MEXICO. ACCORDING TO THE CUSTOMER, THE MALAYSIAN VERSION APPEARED TO HAVE A DIFFERENT COLOR, LESS FIRM, AND FEATURES A LARGER DRAINAGE EYE, WHICH HAS CAUSED IRRITATION. THEY INFORMED THE CUSTOMER THAT SINCE THE CATHETERS MANUFACTURED IN MEXICO AND MALAYSIA SHARED THE SAME REFERENCE NUMBER, THEY WERE EXPECTED TO BE IDENTICAL IN DESIGN AND FUNCTION AND EXPLAINED THAT THE COLOR VARIATION MAY BE DUE TO DIFFERENCES IN RAW MATERIALS USED DURING MANUFACTURING AND SHOULD NOT IMPACT THE CATHETER¿S PERFORMANCE. HOWEVER, THE CUSTOMER REPORTED THAT THE MALAYSIAN VERSION FEELS LESS FIRM, HAS A LARGER DRAINAGE EYE, AND HAS CAUSED IRRITATION, MAKING IT MORE DIFFICULT TO USE. THE CUSTOMER PROVIDED LOT NUMBER NGJY3625 FOR REFERENCE. THEY ADVISED THE CUSTOMER THAT THEY WILL ESCALATE THIS CONCERN AS A PRODUCT COMPLAINT FOR FURTHER INVESTIGATION. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836403 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER FOLEY CATHETER KOD C.R. BARD INC. (COVINGTON) -1018233 NGJY3625 00801741039058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other