BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®

    MDR report key: 17682266 · Received September 5, 2023

    Report

    Report Number
    1018233-2023-06522
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 15, 2023
    Report Date
    November 29, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741073793
    PMA / PMN Number
    K040658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS INCONCLUSIVE. ALTHOUGH AN EXACT ROOT CAUSE COULD NOT BE DETERMINED A POTENTIAL ROOT CAUSE COULD BE ¿INCORRECT OPERATION". VISUAL EVALUATION OF THE RETURNED PHOTO SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), LUBRICANT SYRINGE. VISUAL INSPECTION OF THE PHOTO SAMPLE NOTED THE CAP WAS MISSING FROM THE LUBRICANT SYRINGE. UNABLE TO VERIFY THE REPORTED FAILURE SINCE NO SAMPLE WAS RETURNED FOR EVALUATION; THEREFORE, THIS INVESTIGATION IS CONSIDERED INCONCLUSIVE. 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: ¿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. DIRECTIONS FOR USE: WASH HANDS AND DON CLEAN GLOVES; EXPLAIN PROCEDURE TO PATIENT AND OPEN PERI-CARE KIT; 3. USE THE PROVIDED PACKET OF WIPES TO CLEANSE PATIENT¿S PERIURETHRAL AREA 4. REMOVE GLOVES AND PERFORM HAND HYGIENE WITH PROVIDED ALCOHOL HAND SANITIZER GEL 5. USING PROPER ASEPTIC TECHNIQUE OPEN CSR WRAP 6. DON STERILE GLOVES 7. PLACE UNDERPAD BENEATH PATIENT, PLASTIC/¿SHINY¿ SIDE DOWN NOTE: USE CAUTION TO MAINTAIN ASEPTIC TECHNIQUE 8. POSITION FENESTRATED DRAPE ON PATIENT 9. SATURATE 3 FOAM SWAB STICKS IN POVIDONE IODINE 10.ATTACH THE WATER FILLED SYRINGE TO THE INFLATION PORT NOTE: IT IS NOT NECESSARY TO PRE-TEST THE FOLEY CATHETER BALLOON 11. REMOVE FOLEY CATHETER FROM WRAP AND LUBRICATE CATHETER 12. PREPARE PATIENT WITH 3 FOAM SWAB STICKS SATURATED IN POVIDONE IODINE. USE THE NONDOMINANT HAND FOR THE GENITALIA AND THE DOMINANT HAND FOR THE SWABS NOTE: USE EACH SWAB STICK FOR ONE SWIPE ONLY FEMALE PATIENT: WITH A DOWNWARD STROKE CLEANSE THE RIGHT LABIA MINORA AND DISCARD THE SWAB. DO THE SAME FOR THE LEFT LABIA MINORA. WITH THE LAST SWABSTICK CLEANSE THE MIDDLE AREA BETWEEN THE LABIA INORA MALE PATIENT: CLEANSE THE PENIS IN A CIRCULAR MOTION STARTING AT THE URETHRAL MEATUS AND WORKING OUTWARD 13. PROCEED WITH CATHETERIZATION IN USUAL MANNER USING THE DOMINANT HAND A. WHEN CATHETER TIP HAS ENTERED BLADDER, URINE WILL BE VISIBLE IN THE DRAINAGE TUBE B. INSERT CATHETER TWO MORE INCHES AND INFLATE CATHETER BALLOON 14. INFLATE CATHETER BALLOON USING ENTIRE 10CC OF STERILE WATER PROVIDED IN THE PREFILLED SYRINGE NOTE: USE OF LESS THAN 10CC CAN RESULT IN ASYMMETRICALLY INFLATED BALLOON 15. ONCE INFLATED, GENTLY PULL CATHETER UNTIL THE INFLATED BALLOON IS SNUG AGAINST THE BLADDER NECK 16. SECURE THE FOLEY CATHETER TO THE PATIENT USE THE STATLOCK® FOLEY STABILIZATION DEVICE IF PROVIDED (SEE STATLOCK® FOLEY STABILIZATION DEVICE IFU) NOTE: PLEASE MAKE SURE PATIENT IS APPROPRIATE FOR USE OF STATLOCK® STABILIZATION DEVICE 17. POSITION HANGER ON BED RAIL AT THE FOOT OF THE BED NOTE: EXERCISE CARE TO KEEP BAG OFF THE FLOOR 18. USE GREEN SHEETING CLIP TO SECURE DRAINAGE TUBE TO THE SHEET. MAKE SURE TUBE IS NOT KINKED 19. INDICATE TIME AND DATE OF CATHETER INSERTION ON PROVIDED LABELS. PLACE DESIGNATED LABELS ON PATIENT CHART AND DRAINAGE SYSTEM 20. DOCUMENT PROCEDURE ACCORDING TO HOSPITAL PROTOCOL FOLEY CATHETER REMOVAL 1. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER LOCK OR SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE 2. ALLOW THE PRESSURE WITHIN THE BALLOON TO FORCE THE PLUNGER BACK AND FILL THE SYRINGE WITH WATER. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY 3. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN, PREVENTING BALLOON DEFLATION 4. IF THE BALLOON WILL NOT DEFLATE AND IF PERMITTED BY HOSPITAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. IF THIS FAILS, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL 5. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT¿. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN OPENING THE FOLEY TRAY, THE LUBRICANT SYRINGE DID NOT HAVE A CAP ON, AND THERE WAS VERY LITTLE LUBRICANT LEFT. THE REMAINING LUBRICANT WAS DRIED OUT AND UNUSABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN OPENING THE FOLEY TRAY, THE LUBRICANT SYRINGE DID NOT HAVE A CAP ON, AND THERE WAS VERY LITTLE LUBRICANT LEFT. THE REMAINING LUBRICANT WAS DRIED OUT AND UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122018 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE® FOLEY TRAY MJC C.R. BARD, INC. (COVINGTON) -1018233 NGGX5454 00801741073793

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other