BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIA® FOLEY CATHETER SILICONE COATED

    MDR report key: 7088317 · Received December 6, 2017

    Report

    Report Number
    1018233-2017-06266
    Event Type
    Injury
    Date Received
    December 6, 2017
    Report Date
    December 6, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741095085
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "[DIRECTIONS FOR USE]: 1. METHOD OF USE: THE DEVICE IS INTENDED FOR SINGLE USE ONLY AND IS NOT REUSABLE. (1) CLEANSE THE AREA AROUND THE EXTERNAL URETHRAL MEATUS WITH THE COTTON BALLS IMMERSED IN THE ANTISEPTICS. (2) LUBRICATE THE DISTAL END OF THE CATHETER WITH WATER-SOLUBLE LUBRICANT. (3) INSERT CATHETER INTO THE URETHRAL MEATUS AND ADVANCE IT UNTIL THE BALLOON ENTERS THE BLADDER AND URINE FLOWS OUT THROUGH THE CATHETER. USING A NEEDLE-LESS SYRINGE, INFUSE THE SPECIFIED VOLUME OF STERILE WATER INTO THE INFLATION LUMEN TO INFLATE THE BALLOON. (4) PULL CATHETER TO SEAT THE BALLOON AT THE LEVEL OF THE BLADDER NECK AND SECURE PLACEMENT. (5) TO DEFLATE BALLOON AND REMOVE CATHETER, INSERT A LUER TIP (NEEDLELESS) SYRINGE IN THE INFLATION VALVE TO ALLOW THE WATER TO DRAIN SPONTANEOUSLY. AFTER BALLOON DEFLATION, WITHDRAW THE CATHETER WHILE CONFIRMING THAT NO RESISTANCE IS ENCOUNTERED. 2. PRECAUTIONS FOR USE: (1) WHEN RESISTANCE IS ENCOUNTERED IN INSERTING CATHETER, STOP THE PROCEDURE AND REMOVE THE CATHETER. (2) WHEN DEFLATING BALLOON, DO NOT ASPIRATE WITH A SYRINGE. [THE INFLATION LUMEN FOR BALLOON DEFLATION MAY BE OCCLUDED BY NEGATIVE PRESSURE, AND AS A RESULT THE CATHETER CANNOT BE REMOVED.]. (3) WHEN INSERTING CATHETER WITH A STYLET, CONFIRM THAT THE STYLET HAS REACHED THE TIP OF THE CATHETER, AND MAKE SURE TO KEEP THE STYLET IN PLACE INSIDE THE CATHETER DURING INSERTION. (4) NO SUBSTANCE EXCEPT STERILE WATER SHOULD BE USED TO INFLATE THE BALLOON. (5) DO NOT WIPE CATHETER SURFACE WITH ORGANIC SOLVENTS SUCH AS ALCOHOL. (6) DO NOT ASPIRATE URINE THROUGH DRAINAGE FUNNEL WALL. (7) SINCE MOVEMENT OF THE BODY, ETC. MAY TWIST OR BEND CATHETER TO CAUSE OCCLUSION, CARE SHOULD BE TAKEN TO FIX THE CATHETER SECURELY. (8) WHEN URINARY FLOW CANNOT BE NOTED, CONFIRM THAT THE CATHETER IS NEITHER OCCLUDED NOR BROKEN. (9) WHEN IRRIGATING, OPEN THE CAP OF IRRIGATION FUNNEL AND ATTACH IRRIGATION LINE OR TUBE UNDER ASEPTIC TECHNIQUE. AFTER USE, CLOSE THE CAP." (B)(4). THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION AFTER USING THE CATHETER. THE PATIENT REPORTED THAT THE CATHETER HAD BEEN IN USE FOR FOUR WEEKS. THE PATIENT WAS TREATED WITH ANTIBIOTICS IN THE HOSPITAL OVER THE COURSE OF TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866881 BARDIA® FOLEY CATHETER SILICONE COATED FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 123514A UNK 00801741095085

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R