BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER

    MDR report key: 24718449 · Received March 30, 2026

    Report

    Report Number
    1018233-2026-02077
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 21, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741046308
    PMA / PMN Number
    K070582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. 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. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 BY THE MEDICAL INTENSIVE CARE UNIT THAT FIVE DIFFERENT PATIENTS EXPERIENCED LEAKING WITH SILICONE TEMPERATURE-SENSING FOLEY CATHETERS BETWEEN (B)(6) 2026 AND (B)(6) 2026. ALL AFFECTED DEVICES WERE 16 FR FOLEY CATHETERS, LAWSON NUMBER 1011818. THERE HAD BEEN FEWER REPORTS OF LEAKING SINCE THAT TIME. THE ICU ALSO REPORTED PREVIOUS ISSUES WITH THE WIRE RAISED OUT OF THE SILICONE MATERIAL, WHICH MADE THE FOLEY CATHETER ROUGH AND RESULTED IN SKIN BREAKDOWN FOR PATIENTS. NO MEDICAL INTERVENTION WAS REPORTED. NEW FOLEYS WERE INSERTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE MEDICAL INTENSIVE CARE UNIT THAT FIVE DIFFERENT PATIENTS EXPERIENCED LEAKING (PT 1, PT 2, PT 3, PT 4, PT 5) WITH SILICONE TEMPERATURE SENSING FOLEY CATHETERS BETWEEN 23JAN2026 AND 01FEB2026. ALL AFFECTED DEVICES WERE 16 FR FOLEY CATHETERS, NUMBER 1011818. THERE HAD BEEN FEWER REPORTS OF LEAKING SINCE THAT TIME. THE ICU ALSO REPORTED PREVIOUS ISSUES WITH THE WIRE RAISED OUT OF THE SILICONE MATERIAL, WHICH MADE THE FOLEY CATHETER ROUGH AND RESULTED IN SKIN BREAKDOWN FOR PATIENTS. NO MEDICAL INTERVENTION WAS REPORTED. NEW FOLEYS WERE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122218 BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER FOLEY CATHETER EZL C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741046308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other