BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER

    MDR report key: 20749262 · Received November 21, 2024

    Report

    Report Number
    1018233-2024-07407
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    November 4, 2024
    Report Date
    January 30, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741000287
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. A LABELING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. 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

    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 CUSTOMER JUST RECEIVED FOLEY TRAY. THEY OPENED TWO OF THE KITS OF THE SWABS AND THERE WAS NO IODINE ON THE SWABS. THEY PURCHASED FROM EDGE PARK, BUT THEY REFUSED TO REPLACE, AND THEY HAD TO DISPOSE BECAUSE THE PRODUCT WAS NO LONGER STERILE. CUSTOMER REQUESTED REPLACEMENT OF 2 KITS TRAY1 & TRAY2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER JUST RECEIVED FOLEY TRAY. THEY OPENED TWO OF THE KITS OF THE SWABS AND THERE WAS NO IODINE ON THE SWABS. THEY PURCHASED FROM (B)(6), BUT THEY REFUSED TO REPLACE, AND THEY HAD TO DISPOSE BECAUSE THE PRODUCT WAS NO LONGER STERILE. CUSTOMER REQUESTED REPLACEMENT OF 2 KITS TRAY1 & TRAY2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971784 BARD® FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER FOLEY TRAY EZC C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741000287

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other