BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® ALL-SILICONE FOLEY CATHETER

    MDR report key: 16582326 · Received March 21, 2023

    Report

    Report Number
    1018233-2023-01894
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 28, 2023
    Report Date
    April 19, 2023
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741029752
    PMA / PMN Number
    K040504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS CONFIRMED CAUSE UNKNOWN. VISUAL EVALUATION NOTED RECEIVED 3 PHOTO SAMPLES. FIRST PHOTO SAMPLE SHOWS OUTER PACKAGING OF CATHETER. SECOND AND THIRD PHOTO SAMPLES SHOW END OF CATHETER WITH BALLOON CUFFING AROUND THE END OF CATHETER. ALTHOUGH AN EXACT ROOT CAUSE COULD NOT BE DETERMINED A POTENTIAL ROOT CAUSE COULD BE BALLOON MATERIAL DOES NOT SHRINK QUICKLY ENOUGH. 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: "PROPER TECHNIQUES FOR URINARY CATHETER INSERTION; PERFORM HAND HYGIENE IMMEDIATELY BEFORE AND AFTER INSERTION; INSERT URINARY CATHETERS USING ASEPTIC TECHNIQUE AND STERILE EQUIPMENT; USE THE SMALLEST FOLEY CATHETER POSSIBLE, CONSISTENT WITH GOOD DRAINAGE; DOCUMENT THE INDICATIONS FOR CATHETER INSERTION, DATE AND TIME OF CATHETER INSERTION, INDIVIDUAL WHO INSERTED CATHETER, AND DATE AND TIME OF CATHETER REMOVAL IN PATIENT RECORD; PROPER TECHNIQUES FOR URINARY CATHETER MAINTENANCE; SECURE THE FOLEY CATHETER, USE THE STATLOCK® FOLEY STABILIZATION DEVICE IF PROVIDED; MAINTAIN A CLOSED DRAINAGE SYSTEM BY UTILIZING PRE-CONNECTED, SEALED CATHETER-TUBING JUNCTIONS; MAINTAIN UNOBSTRUCTED URINE FLOW AND KEEP THE CATHETER AND COLLECTION TUBE FREE FROM KINKING; KEEP THE COLLECTION BAG BELOW THE LEVEL OF THE BLADDER OR HIPS AT ALL TIMES; EMPTY THE COLLECTION BAG REGULARLY (E.G., PRIOR TO TRANSPORT) USING A SEPARATE, CLEAN COLLECTION CONTAINER FOR EACH PATIENT; ROUTINE HYGIENE (E.G., CLEANSING OF THE MEATAL SURFACE DURING DAILY BATHING OR SHOWERING) IS APPROPRIATE; LEAVE FOLEY CATHETER IN PLACE ONLY AS LONG AS NEEDED. 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 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. H3 OTHER TEXT: THE ACTUAL/SUSPECTED DEVICE WAS EVALUATED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE 16FR FOLEY KIT. THE ISSUE OCCURRED WHEN THEY TRIED TO REMOVE THE CATHETER, THEY DEFLATED THE BALLOON AND IT APPEARED THE CATHETER ROLLED UP UPON ITSELF. ONE PATIENT WAS MALE AND THEY BROUGHT IN A PHYSICIAN TO TRY AND REMOVE THE CATHETER. AFTER MUCH TIME THEY CUT THE CATHETER AT THE Y WHERE THE INFLATION PORT RESIDED AND THEY WERE ABLE TO REMOVE. THE SECOND ONE WAS A FEMALE BUT SINCE THEY EXPERIENCED THE FIRST ONE, THEY DID THE SAME AND IT CAME OUT. IT WAS NOTED THAT THEIR TEAM AT MH USED THE 14FR KIT AND HAD NO ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE 16FR FOLEY KIT. THE ISSUE OCCURRED WHEN THEY TRIED TO REMOVE THE CATHETER, THEY DEFLATED THE BALLOON AND IT APPEARED THE CATHETER ROLLED UP UPON ITSELF. ONE PATIENT WAS MALE AND THEY BROUGHT IN A PHYSICIAN TO TRY AND REMOVE THE CATHETER. AFTER MUCH TIME THEY CUT THE CATHETER AT THE Y WHERE THE INFLATION PORT RESIDED AND THEY WERE ABLE TO REMOVE. THE SECOND ONE WAS A FEMALE BUT SINCE THEY EXPERIENCED THE FIRST ONE, THEY DID THE SAME AND IT CAME OUT. IT WAS NOTED THAT THEIR TEAM AT MH USED THE 14FR KIT AND HAD NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24909 BARDEX® ALL-SILICONE FOLEY CATHETER FOLEY CATHETER EZL C.R. BARD INC. (COVINGTON) -1018233 165816 NGFX0191 00801741029752

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other