BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY

    MDR report key: 21814259 · Received April 10, 2025

    Report

    Report Number
    1018233-2025-02513
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    February 25, 2025
    Report Date
    November 4, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741040153
    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 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 CONFIRMED- OTHER. RECEIVED (4) PHOTO SAMPLES. THE PHOTO SAMPLE WAS RETURNED AND COULD NOT BE EVALUATED FOR THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED SILICONE FOLEY WITH SAMPLE PORT CONNECTOR AND SYRINGE. VISUAL INSPECTION OF THE SAMPLE NOTED USING THE RETURN SYRINGE TO INFLATE THE CATHETER BALLOON WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) AND WAS ABLE TO INFLATE PROPERLY. WITH THE SYRINGE ATTACHED ATTEMPT TO DEFLATE THE BALLOON AND DID NOT DEFLATE PASSIVELY IN UNDER 5 MIN. USING THE (IN-HOUSE) SYRINGE THE INFLATE THE CATHETER BALLOON WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) AND WAS ABLE TO INFLATE PROPERLY. WITH THE (IN-HOUSE) SYRINGE THE INFLATE THE CATHETER BALLOON WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) AND WAS ABLE TO INFLATE PROPERLY IN UNDER 5 MIN: 1 MIN 23 SEC. THE COMPLAINT AGAINST SYRINGE. INSTRUCTIONS FOR USE WERE REVIEWED FOR THIS INVESTIGATION. THE LABELING IS FOUND TO BE ADEQUATE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. CORRECTIONS: D, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PRE-TEST THE FOLEY CATHETER STERILIZED DISTILLED WATER COULD NOT BE DRAWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PRE-TEST THE FOLEY CATHETER STERILIZED DISTILLED WATER COULD NOT BE DRAWN WITH THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421181 LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY FOLEY CATHETER TRAY MJC C.R. BARD INC. (COVINGTON) -1018233 NGJN1789 00801741040153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other