BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER

    MDR report key: 7820791 · Received August 27, 2018

    Report

    Report Number
    1018233-2018-03812
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    August 10, 2018
    Report Date
    September 28, 2018
    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
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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: ¿BARD® EZ-LOK® SAMPLING PORT (INDICATED BY THE BLUE STEM IN THE PORT) ACCEPTS LUER LOCK (FIG. 1A) OR SLIP TIP SYRINGES (FIG. 1B). 1. OCCLUDE DRAINAGE TUBING A MINIMUM OF 3 INCHES BELOW THE SAMPLING PORT BY KINKING THE TUBING UNTIL URINE IS VISIBLE UNDER THE ACCESS SITE. 2. SWAB SURFACE OF BARD® EZ-LOK® SAMPLING PORT WITH ANTISEPTIC WIPE. (FIG. 2) 3. USING ASEPTIC TECHNIQUE, POSITION THE SYRINGE IN THE CENTER OF THE SAMPLING PORT. PRESS THE SYRINGE FIRMLY AND TWIST GENTLY TO ACCESS THE SAMPLING PORT. (FIG. 3) 4. SLOWLY ASPIRATE URINE SAMPLE INTO SYRINGE AND REMOVE SYRINGE FROM SAMPLE PORT. 5. UNKINK TUBING IF NECESSARY AND TRANSFER URINE SPECIMEN INTO SPECIMEN CUP OR FOLLOW HOSPITAL PROTOCOL. DISCARD SYRINGE ACCORDING TO HOSPITAL PROTOCOL. 6. FOLLOW ESTABLISHED HOSPITAL PROTOCOL FOR SPECIMEN LABELING AND TRANSPORT TO LAB. BARD, EZ-LOK AND STATLOCK ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2018 C. R. BARD, INC. ALL RIGHTS RESERVED. PK7646068 05/2018 WWW.BARDMEDICAL.COM MANUFACTURER: BARD MEDICAL DIVISION C. R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 USA 1.800.526.4455 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 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 EZ-LOK® SAMPLING PORT FIG. 3 FIG. 2 FIG. 1A FIG. 1B STERILIZED USING ETHYLENE OXIDE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BETADINE LEAKED INSIDE THE TRAY AND ONTO THE STERILE DRAPES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BETADINE LEAKED INSIDE THE TRAY AND ONTO THE STERILE DRAPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662360 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER FOLEY TRAY EZC C.R. BARD, INC. (COVINGTON) -1018233 A902916 NGCN0249 00801741074073

    Patients

    Seq Age Sex Outcome Treatment
    1