BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® ALL-SILICONE FOLEY CATHETER

    MDR report key: 8114449 · Received November 29, 2018

    Report

    Report Number
    1018233-2018-05655
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    October 31, 2018
    Report Date
    March 5, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GBM
    UDI-DI
    00801741029745
    PMA / PMN Number
    K760093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED. THE VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING) SILICONE FOLEY. THE CATHETER SHAFT WAS BROKEN IN TWO PIECES 0.3050" FROM THE BIFURCATION. THE DAMAGE TO THE SHAFT WAS OUT OF SPECIFICATION. THE INFLATION ARM WAS FLUSHED WITH METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML OF DISTILLED WATER)WITH NO LEAKS. THE SHAFT WAS FLUSHED WITH METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML OF DISTILLED WATER) WITH NO LEAKS. NO FURTHER TESTING COULD BE DONE ON THE BALLOON SINCE THE CATHETER WAS IN TWO PIECES. ACTIVE LENGTH OF THE CATHETER BALLOON WAS MEASURED (0.6965") AND FOUND TO BE WITHIN SPECIFICATION (0.6"-0.9"). THE CATHETER WAS CONFIRMED TO BE 14 FR. 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: "VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INSERTING THE CATHETER AND CONFIRMING URINE FLOW, THE OPERATOR COULD NOT INFUSE WATER INTO THE CATHETER.

    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 AFTER INSERTING THE CATHETER AND CONFIRMING URINE FLOW, THE OPERATOR COULD NOT INFUSE WATER INTO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956289 BARDEX® ALL-SILICONE FOLEY CATHETER FOLEY CATHETER (SILICONE) GBM C.R. BARD, INC. (COVINGTON) -1018233 165814 NGCQ0203 00801741029745

    Patients

    Seq Age Sex Outcome Treatment
    1