BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® I.C. FOLEY CATHETER

    MDR report key: 8682700 · Received June 10, 2019

    Report

    Report Number
    1018233-2019-02987
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 11, 2019
    Report Date
    July 16, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741016745
    PMA / PMN Number
    K910318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. THE EVALUATION FOUND THAT THE CATHETER COULD BE INFLATED WITHOUT DIFFICULTY. THE CATHETER WAS DISSECTED AND FOUND NO CONDITIONS THAT WOULD CONTRIBUTE TO THE REPORTED PROBLEM. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "(6) INSERT CATHETER INTO URETHRAL MEATUS, AND ADVANCE IT UNTIL THE BALLOON ENTERS THE BLADDER AND URINE FLOWS OUT THROUGH THE CATHETER. USING A SYRINGE PACKAGED IN THE TRAY, INFUSE THE SPECIFIED VOLUME OF STERILE WATER INTO THE INFLATION LUMEN TO INFLATE THE BALLOON." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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 IT WAS DIFFICULT TO INJECT WATER FROM THE INFLATION VALVE. A DENT WAS FOUND ON THE SHAFT ABOUT 14 CM FROM THE TIP.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO INJECT WATER FROM THE INFLATION VALVE. A DENT WAS FOUND ON THE SHAFT ABOUT 14 CM FROM THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479032 BARDEX® I.C. FOLEY CATHETER FOLEY CATHETER (LATEX) MJC C.R. BARD, INC. (COVINGTON) -1018233 0165SI14 8KK0043 00801741016745

    Patients

    Seq Age Sex Outcome Treatment
    1