BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

    MDR report key: 25088825 · Received May 5, 2026

    Report

    Report Number
    1018233-2026-02961
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 19, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741039065
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 BY A PHYSICIAN WHO HAS USED BARD RED RUBBER COUDE TIP CATHETERS FOR DECADES, INSERTING 1X/DAY FOR SELF-TREATMENT OF A URETHRAL STRICTURE. THEIR MOST RECENT BATCH OF CATHETERS ARE VISIBLY AND MEASURE SMALLER IN DIAMETER THAN PRIOR CATHETERS. REF #802518, LOT #NGJW4875. THESE ARE 18FR. RED RUBBER CATHETERS WITH AN EXPECTED OUTER DIAMETER OF 0.236 IN. BY THEIR MEASURE USING A MICROMETER, THESE CATHETERS WERE MEASURING 0.213 IN, AND PRIOR CATHETERS WERE MEASURING ~0.225 OR MORE. THE CURRENT MEASUREMENT WAS 10% SMALLER THAN EXPECTED FOR AN 18FR. SINCE THEY USED THESE TO PREVENT RECURRENCE OF A STRICTURE, THE SMALLER OUTER DIAMETER WAS MORE THAN JUST A QC ISSUE, BUT FOR THEM A MEDICALLY SIGNIFICANT DEVIATION FROM PRIOR CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123368 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER FOLEY CATHETER KOD C.R. BARD INC. (COVINGTON) -1018233 NGJW4875 00801741039065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other