BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® PEDIATRIC ALL-SILICONE FOLEY CATHETER

    MDR report key: 25132834 · Received May 9, 2026

    Report

    Report Number
    1018233-2026-03043
    Event Type
    Malfunction
    Date Received
    May 9, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 6, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741029714
    PMA / PMN Number
    K821745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: 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 BY THE CUSTOMER STATED THAT THEY WOULD LIKE TO INFORM THAT THEY HAD DECIDED TO STOP USING FOLEY CATHETER ITEM P2040329P (CATALOG 165808; DESCRIPTION: FOLEY CATHETER, ROUND TIP, 100 PERCENT SILICONE, 2 WAY, 3ML, 8FR; INTERNAL GRM (B)(4)) FOLLOWING SEVERAL INSTANCES WHERE IT WAS USE RESULTED IN INJURIES TO THEIR PATIENTS. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242665 BARDEX® PEDIATRIC ALL-SILICONE FOLEY CATHETER FOLEY CATHETER KOD C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741029714

    Patients

    Seq Age Sex Outcome Treatment
    1