BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY

    MDR report key: 24226376 · Received January 30, 2026

    Report

    Report Number
    1018233-2026-00493
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 20, 2026
    Report Date
    April 28, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741074127
    PMA / PMN Number
    K040504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME: (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 A CAREGIVER FOUND A HAIR IN FOLEY TRAY KIT. THAT WAS OCCURRED EITHER IN THEIR A942216 OR A942218 TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596929 SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY FOLEY CATHETER EZL C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741074127

    Patients

    Seq Age Sex Outcome Treatment
    1