BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® FOLEY CATHETER SILICONE COATED

    MDR report key: 23879671 · Received December 23, 2025

    Report

    Report Number
    1018233-2025-11425
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 16, 2025
    Report Date
    December 19, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741019203
    PMA / PMN Number
    K922431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME: (B)(6) HOSPITAL. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE PATIENT WAS ADMITTED TO THE GASTROENTEROLOGY DEPARTMENT ON (B)(6) 2025, PRESENTING WITH NAUSEA AND VOMITING FOR 2 DAYS. DUE TO CRITICAL CONDITION, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT ON (B)(6) 2025. DIAGNOSIS 1. ACUTE BILIARY PANCREATITIS 2. GALLBLADDER STONES WITH ACUTE CHOLECYSTITIS. PER PHYSICIAN ORDERS, A SINGLE-USE STERILE URINARY FOLEY CATHETER WAS INDWELLING ON (B)(6) 2025, FOR URINARY DRAINAGE. THE OUTER PACKAGING WAS CAREFULLY INSPECTED FOR INTEGRITY PRIOR TO USE. HALF AN HOUR LATER, THE NURSE DISCOVERED THE IMPLANTED DISPOSABLE STERILE URINARY CATHETER HAD SLIPPED OUT. UPON IMMEDIATE INSPECTION, THE CATHETER'S BALLOON WAS FOUND RUPTURED. AFTER REPLACING THE DISPOSABLE STERILE URINARY CATHETER, THE ISSUE DID NOT RECUR. EXAMINATION REVEALED NO URETHRAL INJURY, AND URINARY DRAINAGE REMAINED NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058391 BARDEX® FOLEY CATHETER SILICONE COATED SILICONE FOLEY CATHETER KOD C.R. BARD INC. (COVINGTON) -1018233 MYJP2142 00801741019203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other