BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER

    MDR report key: 8371797 · Received February 26, 2019

    Report

    Report Number
    1018233-2019-01029
    Event Type
    Injury
    Date Received
    February 26, 2019
    Report Date
    April 16, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741025228
    PMA / PMN Number
    K070582
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED SINCE THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED SILICONE FOLEY WITH THE INLET TUBE AND METER BAG. VISUAL INSPECTION OF THE CATHETER'S SURFACE NOTED NO OBVIOUS VISIBLE DEFECTS; HOWEVER, THERE WAS TAPE AROUND THE TAMPER-EVIDENT SEAL CONNECTION TO THE CATHETER. THE CATHETER BALLOON WAS INFLATED WITH 10ML OF METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML OF DISTILLED WATER) AND THE BALLOON CONCENTRICITY WAS OBSERVED TO BE 60:40. THE BALLOON RESTED FOR 30 MINUTES WITHOUT LEAKS AND PASSIVELY DEFLATED WITHOUT ISSUE, RETURNING 10ML OF SOLUTION. THE DRAINAGE LUMEN WAS FLUSHED WITH METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML OF DISTILLED WATER) WITH NO LEAKS FOUND. THE ACTIVE LENGTH OF THE CATHETER BALLOON WAS MEASURED (0.8475") AND FOUND TO BE WITHIN SPECIFICATION. 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: "STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, EXCEPT FOR ANY INDIVIDUALLY PACKAGED COMPONENTS WITHIN THE TRAY WHICH ARE NOT LABELED AS STERILE. THESE COMPONENTS ARE NOT TERMINALLY STERILIZED. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. SINGLE USE ONLY. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER AND MAY CAUSE BALLOON TO BURST. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICES AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. PLEASE CONSULT PRODUCT LABEL AND INSERT FOR ANY INDICATIONS, CONTRAINDICATIONS, HAZARDS, WARNINGS, CAUTIONS AND DIRECTIONS FOR USE." 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 THE FOLEY BALLOON WAS LEAKING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT VIA EMAIL ON 18-FEB-2019, THAT 30CC OF STERILE WATER WAS USED TO INFLATE THE BALLOON. APPROXIMATELY 2 HOURS LATER, THE PATIENT STATED SHE FELT A GUSH OF LIQUID. IT WAS LATER DETERMINED BY THE PHYSICIAN ON CALL THAT THE BALLOON HAD A TEAR WHICH CAUSED A LEAK. IT WAS DETERMINED THAT NO BALLOON PARTICLES WERE LEFT IN THE CERVIX/VAGINAL CANAL AFTER AN EXAM WAS PERFORMED TO ENSURE NO RESIDUAL BALLOON WAS LEFT IN THE PATIENT.

    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 THE FOLEY BALLOON WAS LEAKING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT VIA EMAIL ON (B)(6) 2019, THAT 30CC OF STERILE WATER WAS USED TO INFLATE THE BALLOON. APPROXIMATELY 2 HOURS LATER, THE PATIENT STATED SHE FELT A GUSH OF LIQUID. IT WAS LATER DETERMINED BY THE PHYSICIAN ON CALL THAT THE BALLOON HAD A TEAR WHICH CAUSED A LEAK. IT WAS DETERMINED THAT NO BALLOON PARTICLES WERE LEFT IN THE CERVIX/VAGINAL CANAL AFTER AN EXAM WAS PERFORMED TO ENSURE NO RESIDUAL BALLOON WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163522 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER SILICONE FOLEY CATHETER MJC C.R. BARD, INC. (COVINGTON) -1018233 1758SI16 NGCV1427 00801741025228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention