BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22293497 · Received June 19, 2025

    Report

    Report Number
    1018233-2025-04771
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 30, 2025
    Report Date
    December 15, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741039850
    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 HAS BEEN CONFIRMED AND IS BEING INVESTIGATED BY CAPAS 12866756 & 12474528. RECEIVED 1 ALL-SILICONE FOLEY CATHETER. VERIFIED MATERIAL NUMBER 1191316 AND MANUFACTURING LOT NUMBER NGHY1465. VISUAL INSPECTION NOTED THE BALLOON HAD BURST MEASURING 0.2605". FURTHER INSPECTION NOTED THE BALLOON HAD NO MISSING PIECES. THIS IS OUT OF SPECIFICATION PER INSPECTION PROCEDURE (B)(4), REVISION 13, WHICH STATES, "BALLOON MUST NOT BE TORN". THIS IS OUT OF SPECIFICATION PER INSPECTION PROCEDURE IP7603444, REVISION 0, WHICH STATES, "CATHETER LEAKS, VALVE LEAKS, BALLOON PERFORATION, LUMEN TO LUMEN, PREMATURELY DEFLATED AND DISLODGED BALLOON ARE NOT ALLOWED, AND MUST INFLATE AND DEFLATE WITH THE USE OF A SYRINGE." RISK REVIEW, LABELING REVIEW, AND DHR REVIEW ARE NOT REQUIRED AS THE EVENT IS BEING INVESTIGATED PER CAPAS 12866756 & 12474528. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED IN THE OPERATING ROOM. IT WAS NATURALLY REMOVED ABOUT TWO DAYS AFTER THE PATIENT WAS MOVED TO THE WARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED IN THE OPERATING ROOM. IT WAS NATURALLY REMOVED ABOUT TWO DAYS AFTER THE PATIENT WAS MOVED TO THE WARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788197 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER FOLEY CATHETER MJC C.R. BARD INC. (COVINGTON) -1018233 NGHY1465 00801741039850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other