BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22629929 · Received July 28, 2025

    Report

    Report Number
    1018233-2025-06199
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 15, 2025
    Report Date
    December 18, 2025
    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 VIA CAPA ASSOCIATED. THIS IS ADDRESSED BY CAPA 12474540. PHOTO SAMPLES WERE SUBMITTED SHOWING THE CATHETER DEFLATED, NO VISIBLE DEFECTS WERE NOTED FROM THE PHOTOS. THE ALL-SILICONE TEMP SENSING FOLEY CATHETER WITH SAMPLE PORT CONNECTOR, SYRINGE AND PACKAGING LABEL WERE RETURNED. THE CATHETER BALLOON WAS INFLATED WITH 10ML METHYLENE BLUE SOLUTION (MBS) USING THE RETURNED SYRINGE. THE BALLOON WAS NOTED TO INFLATED ASYMMETRICALLY (100;0) PER TM0300903 REV 3; THIS FAILURE IS DOCUMENTED AND INVESTIGATED VIA CAPA 11291030. AN ATTEMPT WAS MADE TO DEFLATE THE CATHETER BALLOON, HOWEVER, ONLY 9ML DEFLATED IN 5 MINUTES. PER IP7603444 REVISION 0, THE CATHETER MUST INFLATE AND DEFLATE WITH A SYRINGE. THE CATHETER BALLOON WAS THEN INFLATED WITH 10ML MBS USING AN IN-HOUSE SYRINGE, THE BALLOON PASSIVELY DEFLATED IN 1MIN30SEC. THE REPORTED EVENT IS CONFIRMED AGAINST THE RETURNED SYRINGE. CAPA 12474540 IDENTIFIED THE ROOT CAUSE OF THIS FAILURE AS A COMBINATION OF THREE (3) FACTORS; PROVIDED WATER SYRINGE DOES NOT MEET USER EXPECTATION FOR SMOOTH ENGAGEMENT WITH THE VALVE AND NO INSTRUCTIONS ARE PROVIDED IN THE JAPANESE IFU FOR ASPIRATING TO ASSIST IN DEFLATION, DEFLATION TIME OR TAKE OFF FORCE CRITERIA OR SPECIFICATION TO DEFLATE THE CATHETER HAS NOT BEEN DETERMINED AND IT IS UNKNOWN FOR THE CUSTOMERS, INADEQUATE PROCESS QUALIFICATION PERFORMED WITH CHANGE IN SYRINGE SUPPLIER AND MOLD CHANGE. RISK REVIEW, LABELING REVIEW, AND DHR REVIEW ARE NOT REQUIRED AS EVENT HAS ALREADY BEEN INVESTIGATED PER CAPA 12474540, HOWEVER, DHR REVIEW WAS COMPLETED PRIOR TO CAPA DETERMINATION. CORRECTIONS: D, F, H. 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: 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 PRE-TEST, STERILIZED WATER COULD NOT BE REMOVED FROM THE FOLEY CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-TEST, STERILIZED WATER COULD NOT BE REMOVED FROM THE FOLEY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20266 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER FOLEY CATHETER MJC C.R. BARD INC. (COVINGTON) -1018233 MYKN7360 00801741039843

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other