BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® FOLEY CATHETER SILICONE COATED

    MDR report key: 19476899 · Received June 6, 2024

    Report

    Report Number
    1018233-2024-03354
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    April 18, 2024
    Report Date
    June 28, 2024
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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 REPORTED EVENT WAS CONFIRMED ¿ CAUSE UNKNOWN. THE REPORTED FAILURE WAS ABLE TO BE REPRODUCED. VISUAL INSPECTION NOTED IRREGULAR BURST WITHOUT MISSING PIECES. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE USER RELATED (EXAMPLE: CONTACT WITH SHARP OBJECT)/EXPOSURE TO PETROLATUM BASED PRODUCTS/MECHANICAL FAILURE/OPERATOR ERROR. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO THIN SAC THAT MAY LEAD TO BURST BALLOON. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "WARNINGS: CONCERNING USE: SINCE IT MAY BE DIFFICULT TO REMOVE CATHETER EVEN AFTER BALLOON DEFLATION IN SOME CASES, THE CATHETER SHOULD BE REMOVED. WYER INSERTING CATHETER WITH A STYLET, THIS THAT THE STYLET HAS REACHED THE TIP OF THE CATHETER, AND THEN INSERT WITHOUT PULLING. OTHERWISE, THE STYLET MAY EXIT THE SIDE HOLE TO DAMAGE THE URETHRAL MUCOSA. WHEN DEFLATING BALLOON, ALLOW BALLOON TO DEFLATE ON ITS OWN; DO NOT USE EXCESSIVE FORCE IN ASPIRATING WITH A SYRINGE. THE INFLATION LUMEN FOR BALLOON DEFLATION MAY BE OCCLUDED BY NEGATIVE PRESSURE, AS A RESULT THE BALLOON CANNOT BE DEFLATED. WHEN CATHETER IS INADVERTENTLY REMOVED, INSPECT THE BALLOON AND SHAFT OF CATHETER FOR RUPTURE, DAMAGE ETC. BEFORE INSERTING A NEW CATHETER. FRAGMENTS OF THE BALLOON OR SEGMENT OF CATHETER MAY REMAIN IN THE BLADDER. CAUTION SHOULD BE EXERCISED IN THE FOLLOWING PATIENTS: USE WITH GREAT CARE FOR PATIENTS WITH DISTURBANCE OF CONSCIOUSNESS, ETC. WHEN PATIENT REMOVES CATHETER UNCONSCIOUSLY, THE MUCOSA OF THE BLADDER AND URETHRA MAY BE DAMAGED, BALLOON MAY BE RUPTURES, CATHETER MAY BE BROKEN, AND CATHETER FRAGMENTS MAY BE LEFT BEHIND IN THE BLADDER. CONTRAINDICATIONS/PROHIBITIONS: CONCERNING USE: DO NOT REUSE. THE BALLOON AND SHAF OF CATHETER SHOULD NOT BE PINCHED WITH FORCEPS, ETC. DAMAGE TO THE CATHETER WITH A BLADE OR SHARP-EDGED DEVICES MUST BE AVOIDED. THERE IS A STRONG LIKELIHOOD THAT BREAKAGE OR SPONTANEOUS REMOVAL OF CATHETER, OR RUPTURE OF BALLOON WILL OCCUR, AND THAT INABILITY OF BALLOON TO DEFLATE MAY MAKE REMOVAL OF THE CATHETER DIFFICULT. PRECAUTIONS: THIS PRODUCT IS CONTRAINDICATED IN THE FOLLOWING PATIENTS: PATIENT'S WITH A PAST HISTORY OF ALLERGIC REACTIONS TO NATURAL RUBBER. PROHIBITED CONCOMITANT USE: DO NOT USE OINTMENTS, CONTRAST MEDIUM OR LUBRICANTS HAVING PETROLEUM BASE ON CATHETER (INCLUDING OIL OF ANIMAL OR PLANT ORIGIN, SUCH AS OLIVE OIL AND PETROLEUM JELLY, AND MINERAL OIL.) THEY WILL DAMAGE LATEX AND MAY CAUSE BALLOON TO BURST. DO NOT WIPE CATHETER SURFACE WITH ORGANIC SOLVENTS (SUCH AS ALCOHOL). NO SUBSTANCE EXCEPT STERILE WATER SHOULD BE USED TO INFLATE THE BALLOON. A CONTRAST MEDIUM MAY CAUSE BALLOON TO BURST. IF NORMAL SALINE IS USED, CRYSTALLIZED SALT MAY OCCLUDE THE INFLATION LUMEN TO PREVENT DEFLATION OF THE BALLOON. WHEN AIR IS USED, AIR MAY ESCAPE TO CAUSE SPONTANEOUS DEFLATION OF THE BALLOON SO THAT THE CATHETER MAY COME OUT PREMATURELY. INDICATIONS FOR USE: THIS DEVICE IS AN INDWELLING CATHETER IN THE BLADDER FOR URINARY DRAINAGE. PRECAUTIONS: PRECAUTIONS FOR USE - NATURAL RUBBER MAY CAUSE ALLERGIC SYMPTOMS INCLUDING ITCHING, REDNESS, URTICARIA, SWELLING FEVER, DYSPNEA, ASTHMA-LIKE SYMPTOMS, DECREASED BLOOD PRESSURE, SHOCK, ETC. WHEN SUCH SYMPTOMS APPEAR, USE OF THE DEVICE SHOULD BE STOPPED IMMEDIATELY, AND CONSULT THE ATTENDING PHYSICIAN SO THAT APPROPRIATE MEASURES SHOULD BE TAKEN." 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 A MALE PATIENT (70 YEARS OLD) HAD FOUR CONSECUTIVE BALLOON RUPTURES. ON 18APR, THE PATIENT WAS TRANSFERRED HOME FROM HOSPITAL. 9960014LRS TO 123514 BALLOON WAS EXCHANGED. THERE WERE NO PROBLEMS DURING THE PRE-TEST, BUT THERE WAS A POPPING SOUND WHEN INJECTING STERILE DISTILLED WATER AFTER INSERTION. THE BALLOON WAS REPLACED AT THAT POINT DUE TO RUPTURE. ON 26APR THEY RECEIVED A CALL ABOUT SPONTANEOUS REMOVAL, AND UPON CHECKING, THEY FOUND THAT THE BALLOON PART WAS DAMAGED. THE PATIENT HAD NO BLEEDING OR PAIN. THEY INSERTED A NEW FOLEY CATHETER. THE FOLEY CATHETER WAS SPONTANEOUSLY REMOVED ON 16MAY. THE BALLOON WOULD BE REPLACED WITH 9960014LRS. THE PATIENT HAD NO BLEEDING OR PAIN. ON 18MAY, THEY WERE INFORMED THAT THE CATHETER HAD BEEN REMOVED NATURALLY. WHEN FOLEY WAS CHECKED, THE BALLOON PART WAS DAMAGED. THE PATIENT HAD NO BLEEDING OR PAIN. THEN THEY USED A 16FR CATHETER MADE BY ANOTHER MANUFACTURER. THEY USED CAIN ZERO JELLY TO INSERT THE BALLOON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT (70 YEARS OLD) HAD FOUR CONSECUTIVE BALLOON RUPTURES. ON (B)(6), THE PATIENT WAS TRANSFERRED HOME FROM HOSPITAL. 9960014LRS TO 123514 BALLOON WAS EXCHANGED. THERE WERE NO PROBLEMS DURING THE PRE-TEST, BUT THERE WAS A POPPING SOUND WHEN INJECTING STERILE DISTILLED WATER AFTER INSERTION. THE BALLOON WAS REPLACED AT THAT POINT DUE TO RUPTURE. ON (B)(6), THEY RECEIVED A CALL ABOUT SPONTANEOUS REMOVAL, AND UPON CHECKING, THEY FOUND THAT THE BALLOON PART WAS DAMAGED. THE PATIENT HAD NO BLEEDING OR PAIN. THEY INSERTED A NEW FOLEY CATHETER. THE FOLEY CATHETER WAS SPONTANEOUSLY REMOVED ON (B)(6). THE BALLOON WOULD BE REPLACED WITH 9960014LRS. THE PATIENT HAD NO BLEEDING OR PAIN. ON (B)(6), THEY WERE INFORMED THAT THE CATHETER HAD BEEN REMOVED NATURALLY. WHEN FOLEY WAS CHECKED, THE BALLOON PART WAS DAMAGED. THE PATIENT HAD NO BLEEDING OR PAIN. THEN THEY USED A 16FR CATHETER MADE BY ANOTHER MANUFACTURER. THEY USED CAIN ZERO JELLY TO INSERT THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2885 BARDIA® FOLEY CATHETER SILICONE COATED FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 MYGW0176

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other