BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24226377 · Received January 30, 2026

    Report

    Report Number
    1018233-2026-00494
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 16, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741074110
    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

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATE: STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, EXCEPT FOR ANY INDIVIDUALLY PACKAGED COMPONENTS WITHIN THE TRAY WHICH ARE NOT LABELED AS STERILE. THESE COMPONENTS ARE NOT TERMINALLY STERILIZED. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: 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.

    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 (B)(6) OR (B)(6)TRAY.

    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
    284066 SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY SILICONE FOLEY TRAY EZL C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741074110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other