BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23257349 · Received October 9, 2025

    Report

    Report Number
    1018233-2025-08953
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 25, 2025
    Report Date
    March 5, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741039843
    PMA / PMN Number
    K070582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS CONFIRMED MANUFACTURING RELATED. THIS IS ADDRESSED BY CAPA 11881143. PHOTO SAMPLE EVALUATION: RECEIVED (9) PHOTO SAMPLES. VISUAL EVALUATION OF THE PHOTO SAMPLES NOTED AN OPENED USED DRAINAGE BAG WITH TUBE CONNECTED WITH TEMP-SENSING FOLEY CATHETER WITH SYRINGE. VERIFIED MATERIAL NUMBER 29000J14, BATCH NUMBER MYKN5228, MATERIAL NUMBER FOR CATHETER 119314 WITH MANUFACTURING LOT NUMBER NGJX4584, DRAINAGE BAG WITH LOT # 241216. THE CONDITION OF THE AFFECTED CATHETER AND DRAINAGE BAG COULD NOT BE CONFIRMED FROM THE PHOTOS PROVIDED. FUNCTIONAL TESTING WAS NOT POSSIBLE BASED SOLELY ON THESE PHOTOS. RECEIVED 1 ALL SILICONE FOLEY CATHETER WITH SYRINGE ATTACHED TO THE DRAINAGE BAG. VERIFIED MATERIAL NUMBER 119314 AND MANUFACTURING LOT NUMBER NGJX4584. VISUAL INSPECTION NOTED NO OBVIOUS OBSERVATIONS. THE CATHETER URINE LUMEN FILLED WITH 10ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) USING RETURNED SYRINGE AND BLOCKAGE WAS PRESENT AT URINE LUMEN. THIS IS OUT OF SPECIFICATION PER INSPECTION PROCEDURE, WHICH STATES, "THE MATERIAL MUST NOT OCCLUDE THE IRRIGATION AND INFLATION NOTCH NEITHER THE EYES WHEN MOLDING THE TIP." RISK REVIEW, LABELING REVIEW, AND DHR REVIEW ARE NOT REQUIRED AS EVENT HAS ALREADY BEEN INVESTIGATED PER CAPA 11881143. CORRECTIONS: D, F, H INITIAL REPORTER NAME: (B)(6) HOSPITAL, (B)(6), 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER NAME: (B)(6) HOSPITAL. 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 DURING PLACEMENT FOLEY CATHETER DRAINAGE LUMEN HAD OCCLUSION. NO URINE OUTPUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PLACEMENT FOLEY CATHETER DRAINAGE LUMEN HAD OCCLUSION. NO URINE OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545379 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER TEMPERATURE SENSING FOLEY CATHETER MJC C.R. BARD INC. (COVINGTON) -1018233 NGJX4584 00801741039843

    Patients

    Seq Age Sex Outcome Treatment
    1