BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER

    MDR report key: 23770345 · Received December 10, 2025

    Report

    Report Number
    1018233-2025-10960
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 18, 2025
    Report Date
    February 5, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741025211
    PMA / PMN Number
    K984136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER'S FACILITY NAME: IYO HOSPITAL, MEDICAL CORPORATION FOUNDATION SHOONKAI. THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATES, CONTRAINDICATIONS: (4) BE CAREFUL THAT THE CATHETER IS NOT EXPOSED TO OINTMENTS, CONTRAST MEDIUM OR OIL-BASED LUBRICANTS (INCLUDING VEGETABLE OILS SUCH AS OLIVE OIL, MINERAL OILS SUCH AS WHITE PETROLATUM AND ANIMAL OILS). THEY MAY DAMAGE THE DEVICE AND MAY BURST BALLOON. DIRECTIONS FOR USE: (3) CAREFULLY INSERT THE CATHETER INTO THE URETHRAL MEATUS. AFTER THE BALLOON ADVANCED IN THE BLADDER, ATTACH THE NEEDLELESS SYRINGE, AND GENTLY INFUSE THE SPECIFIED VOLUME OF STERILE WATER TO INFLATE THE BALLOON. PRECAUTIONS FOR USE: (6) INSERT CATHETER INTO THE URETHRAL MEATUS AND ADVANCE IT UNTIL THE BALLOON ENTERS THE BLADDER AND URINE FLOWS OUT THROUGH THE CATHETER. USING A SYRINGE PACKAGED IN THE TRAY, INFUSE THE SPECIFIED VOLUME OF STERILE WATER INTO THE INFLATION LUMEN TO INFLATE THE BALLOON. (FIG. 5). (12) WHEN RESISTANCE IS ENCOUNTERED IN INSERTING CATHETER, STOP THE PROCEDURE AND REMOVE THE CATHETER. (13) WHEN DEFLATING BALLOON, DO NOT ASPIRATE WITH A SYRINGE BY HANDS. THE INFLATION LUMEN FOR BALLOON DEFLATION MAY BE OCCLUDED BY NEGATIVE PRESSURE, AND AS A RESULT THE CATHETER CANNOT BE REMOVED. (20) DO NOT ASPIRATE URINE THROUGH DRAINAGE FUNNEL WALL. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTIONS: D, F, H: THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. H11: SECTIONS 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 COMPLETE INITIAL REPORTER'S FACILITY NAME: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. H11: SECTIONS 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 THERE WAS A WATER LEAK FROM THE FUNNEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A WATER LEAK FROM THE FUNNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568200 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER FOLEY CATHETER MJC C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741025211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other