BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL® FEMALE CATH KIT

    MDR report key: 23889046 · Received December 24, 2025

    Report

    Report Number
    1018233-2025-11434
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    December 17, 2025
    Report Date
    December 23, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FFH
    UDI-DI
    00801741045820
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 THAT THE FEMALE CATHETER THAT GOES INTO THE PATIENT WAS VERY LOOSE/SLIDING OUT OF THE HOLDER INSERTING OR GOING BACK INTO THE HOLDER INSTEAD OF INTO THE PATIENT. CLINIC HAD 2 LIKE THIS BUT MANAGED TO HOLD THEM IN ORDER TO USE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476062 DAVOL® FEMALE CATH KIT CATHETER KIT FFH C.R. BARD INC. (COVINGTON) -1018233 NGKS2201 00801741045820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other