BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER

    MDR report key: 20693884 · Received November 15, 2024

    Report

    Report Number
    1018233-2024-07238
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 22, 2024
    Report Date
    February 12, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741074073
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 INCONCLUSIVE. THE CONDITIONS OF THE SAMPLE DID NOT ALLOW FURTHER EVALUATION. VISUAL EVALUATION OF THE RETURNED ONE PHOTO SAMPLE NOTED ONE OPENED (WITH ORIGINAL PACKAGING), FOR A SURESTEP FOLEY TRAYS. VISUAL INSPECTION OF THE ONE PHOTO SAMPLE NOTED THAT THE REPORTED FAILURE WAS UNABLE TO BE EVALUATED DUE TO THE POOR CONDITION OF THE PHOTO SAMPLE THEREFORE THIS INVESTIGATION IS CONSIDERED INCONCLUSIVE. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. 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 STATES 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. DIRECTIONS FOR USE: 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 PRECONNECTED, 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 BATH. CORRECTION- D, F, H. THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. 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 IODINE SWABS HAD BEEN REMOVED FROM THE PACKING AND WERE JUST LYING IN THE FOLEY TRAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IODINE SWABS HAD BEEN REMOVED FROM THE PACKING AND WERE JUST LYING IN THE FOLEY TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196252 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER FOLEY TRAY EZC C.R. BARD, INC. (COVINGTON) -1018233 NGJT1679 00801741074073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other