BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® COUDE OLIVE TIP URETHRAL CATHETER

    MDR report key: 23544848 · Received November 13, 2025

    Report

    Report Number
    1018233-2025-10263
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 21, 2025
    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
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, IT WAS FOUND THAT 1018233-2025-10263 HAD NO ALLEGATION AGAINST DEVICE. THEREFORE, A RETRACTION IS BEING SUBMITTED. ALL AVAILABLE UDI INFORMATION IS BEING PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. ALL AVAILABLE UDI INFORMATION IS BEING PROVIDED. 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 PATIENT SAID THEY WERE RECEIVING MANUFACTURER BOXES WITH COUDE INTERMITTENT CATHETER 802518 ON THEM BUT INSIDE ARE 802516. PER CUSTOMER VIA PHONE ON 13NOV2025, IT WAS REPORTED THAT THERE WAS NO COMPLAINT AGAINST THE PRODUCT. CUSTOMER EXPLAINED THAT PRIOR TO RECEIVING THE MOST RECENT ORDER OF 802518, HE PREVIOUSLY USED 802516. CUSTOMER BELIEVES THAT THEY WERE RESPONSIBLE FOR MIXING THE TWO DIFFERENT SIZE CATHETERS AFTER TAKING THEM OUT OF THE CORRECTLY LABELED OUTER BOXES. CUSTOMER STATED THAT THE OUTER BOXES HAVE ALL BEEN SENT OUT TO RECYCLE BIN AND NO PHOTO OR PHYSICAL SAMPLE WAS AVAILABLE. NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SAID THEY WERE RECEIVING MANUFACTURER BOXES WITH COUDE INTERMITTENT CATHETER 802518 ON THEM BUT INSIDE ARE 802516.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984434 BARDIA® COUDE OLIVE TIP URETHRAL CATHETER FOLEY CATHETER KOD C.R. BARD INC. (COVINGTON) -1018233 NGKT1885 00801741039065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other