BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL® FEMALE CATH KIT

    MDR report key: 23480137 · Received November 5, 2025

    Report

    Report Number
    1018233-2025-09962
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 18, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FFH
    UDI-DI
    00801741045837
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER'S LAST 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: 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.

    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. A LABELING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D. 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 HOSPITAL USER STATED THAT THEY WERE GIVEN THE PACKAGE OF A DEFECTIVE BARD FEMALE CATHETER KIT 8 FR., SKU 0035720 FROM THEIR EMERGENCY DEPARTMENT. THEY MENTIONED THAT THE CATHETER TUBE WAS BROKEN IN HALF, BUT THEY DID NOT KEEP THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOSPITAL USER STATED THAT THEY WERE GIVEN THE PACKAGE OF A DEFECTIVE BARD FEMALE CATHETER KIT 8 FR., SKU 0035720 FROM THEIR EMERGENCY DEPARTMENT. THEY MENTIONED THAT THE CATHETER TUBE WAS BROKEN IN HALF, BUT THEY DID NOT KEEP THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607301 DAVOL® FEMALE CATH KIT CATHETER KIT FFH C.R. BARD, INC. (COVINGTON) -1018233 NGJX3671 00801741045837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other