BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

    MDR report key: 24677168 · Received March 24, 2026

    Report

    Report Number
    1018233-2026-01985
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 14, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741034145
    PMA / PMN Number
    K984084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE 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: 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 HAD ISSUE WHEN INFLATING BALLOON WITH 10MLS OF WATER WHICH WAS INCLUDED IN THE TRAY AND THE BALLOON APPARENTLY 'POPPED'. NEW CATHETER REINSERTED. IT ADVISED TO CONTACT YOU REGARDING TWO INCIDENTS THAT WERE RAISED CONCERNING DEFECTIVE CATHETERS. ON VISITING THIS PATIENT FOR A BLOCKED CATHETER, WHEN INSERTING THE NEW CATHETER AND INFLATING THE BALLOON A POPPING NOISE WAS HEARD AND URINE WAS SEEN IN THE 10ML INFLATING SYRINGE, PERMISSION GAINED TO REMOVE CATHETER AND ON CLOSE INSPECTION OF THE CATHETER IT APPEARS THE BALLOON HAD POPPED AND WOULD NOT INFLATE THEREFORE IS WAS IDENTIFIED AS A FAULTY CATHETER, CATHETER DETAILS LUBRI-SIL BARD TRAY 12CH LOT-NGKT3823 EXP-10/12/2027, NEW CATHETER INSERTED WITH NIL ISSUES NO HARM CAME TO PATIENT. UNFORTUNATELY, THE CATHETER WASN¿T RETAINED BY THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275563 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER FOLEY CATHETER EZL C.R. BARD INC. (COVINGTON) -1018233 NGKT3823 00801741034145

    Patients

    Seq Age Sex Outcome Treatment
    1