BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23505146 · Received November 8, 2025

    Report

    Report Number
    1018233-2025-10110
    Event Type
    Malfunction
    Date Received
    November 8, 2025
    Date of Event
    October 29, 2025
    Report Date
    March 13, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741025211
    PMA / PMN Number
    K984136
    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 UNCONFIRMED AS THE PRODUCT MEETS SPECIFICATIONS. RECEIVED 1 ALL-SILICONE FOLEY CATHETER WITH SAMPLE PORT CONNECTOR AND SYRINGE. VERIFIED MATERIAL NUMBER 2758J14 AND MANUFACTURING LOT NUMBER NGJU0236. VISUAL INSPECTION NOTED NO OBVIOUS OBSERVATIONS. THE CATHETER BALLOON WAS INFLATED WITH 10ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) USING THE RETURNED SYRINGE AND THE CATHETER RESTED WITH NO LEAKS. THE BALLOON WAS DEFLATED WITHIN IN 1 MIN 24SEC WITH NO CUFFING NOTED. THIS IS WITHIN SPECIFICATION PER INSPECTION PROCEDURE (B)(6), REVISION 0, WHICH STATES, CATHETER LEAKS, VALVE LEAKS, BALLOON PERFORATION, LUMEN TO LUMEN, PREMATURELY DEFLATED AND DISL ODGED BALLOON ARE NOT ALLOWED, AND MUST INFLATE AND DEFLATE WITH THE USE OF A SYRINGE. THEREFORE, THE REPORTED EVENT IS UNCONFIRMED. RISK, LABELLING, AND DHR REVIEWS ARE NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE NEEDED. CORRECTION: D,F,G,H THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. 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 INITIAL REPORTER'S PHONE NUMBER: (B)(6). THE INITIAL REPORTER'S FAX NUMBER: (B)(6). 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 THAT DURING USE THE FOLEY CATHETER STERILE WATER COULD NOT BE INJECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER STERILE WATER COULD NOT BE INJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510333 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER SENSING FOLEY CATHETER MJC C.R. BARD INC. (COVINGTON) -1018233 NGJU0236 00801741025211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other