BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21993824 · Received May 9, 2025

    Report

    Report Number
    1018233-2025-03372
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 14, 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

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR. THERE IS NO ALLEGATION AGAINST A BD PRODUCT BUT ON A COMPONENT IN THE TRAY. THIS REPORT IS BEING SUBMITTED AS ADDITIONAL INFORMATION. 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 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 NO LEAKS. WITH THE RETURN SYRINGE ATTACHED ATTEMPT TO DEFLATE THE BALLOON AND DID NOT DEFLATE PASSIVELY IN UNDER 5 MIN 4ML COULD BE WITHDRAWN. 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 DEFLATE PROPERLY WITH NO CUFFING OR LEAKS IN UNDER 5 MIN: 1 MIN 40 SEC. THE COMPLAINT IS AGAINST SYRINGE. THE LABELING IS FOUND TO BE ADEQUATE. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. CORRECTIONS: D, E, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE FOLEY CATHETER WAS PRETESTED IN THE OPERATING THEATRE TO BE PLACED FOR URINARY DRAINAGE AND TEMPERATURE CONTROL, THE INJECTED STERILE WATER DID NOT DRAIN OUT. SO, IT WAS NOT USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE FOLEY TRAY SYRINGE WAS PRETESTED IN THE OPERATING THEATRE TO BE PLACED FOR URINARY DRAINAGE AND TEMPERATURE CONTROL, THE INJECTED STERILE WATER DID NOT DRAIN OUT. SO, IT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272722 LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY FOLEY TRAY MJC C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741040153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other