BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP

    MDR report key: 21994701 · Received May 9, 2025

    Report

    Report Number
    1018233-2025-03386
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 22, 2025
    Report Date
    June 19, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741017810
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME SINCE ROOT CAUSE WAS NOT IDENTIFIED. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. A LABELING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED ISSUE. 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 FOLEY CATHETERS WERE SHEDDING PARTICLES (PCN#0168L14 AND PCN#175814).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETERS WERE SHEDDING PARTICLES (PCN#: 0168L14 AND PCN#: 175814).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034585 BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741017810

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other