BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT

    MDR report key: 7894824 · Received September 20, 2018

    Report

    Report Number
    1018233-2018-04312
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Report Date
    October 11, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FCM
    UDI-DI
    00801741030574
    PMA / PMN Number
    K910653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WAS FOUND ADEQUATE AND STATES THE FOLLOWING: "TOUCHLESS¿ PLUS UNISEX PRE-LUBRICATED URETHRAL CATHETER KIT CONTENTS: VINYL URETHRAL CATHETER 1100CC COLLECTION BAG 3 POVIDONE-IODINE SWABS 2 AMBIDEXTROUS GLOVES WATERPROOF UNDERPAD UNITS UNITÉS UNIDADES STERILIZED USING ETHYLENE OXIDE STÉRILISÉ À L¿OXYDE D¿ÉTHYLÈNE ESTERILIZADO MEDIANTE ÓXIDO DE ETILENO CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. ATTENTION : SELON LA LOI FÉDÉRALE AMÉRICAINE, CE DISPOSITIF NE PEUT ÊTRE VENDU QUE PAR UN MÉDECIN OU SUR PRESCRIPTION MÉDICALE. AVISO: LAS LEYES FEDERALES (DE EE.UU.) LIMITAN LA VENTA DE ESTE DISPOSITIVO A MÉDICOS O BAJO PRESCRIPCIÓN FACULTATIVA. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND WITH APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. APRÈS USAGE, CE PRODUIT PEUT PRÉSENTER UN RISQUE BIOLOGIQUE POTENTIEL. LE MANIPULER ET LE JETER CONFORMÉMENT À LA PRATIQUE MÉDICALE ACCEPTÉE ET AUX LOIS ET RÉGLEMENTATIONS LOCALES, NATIONALES ET FÉDÉRALES EN VIGUEUR. DESPUÉS DEL USO, ESTE PRODUCTO PUEDE SUPONER UN PELIGRO BIOLÓGICO. MANIPÚLELO Y DESÉCHELO CONFORME A LA PRÁCTICA MÉDICA ACEPTADA Y A LAS LEYES Y NORMATIVAS LOCALES, ESTATALES Y FEDERALES PERTINENTES. SINGLE USE À USAGE UNIQUE UN SOLO USO DO NOT RESTERILIZE. NE PAS RESTÉRILISER. NO REESTERILIZAR. DO NOT USE IF PACKAGE IS DAMAGED. NE PAS UTILISER SI L¿EMBALLAGE EST ENDOMMAGÉ. NO USAR SI EL ENVASE ESTÁ DAÑADO. MANUFACTURED IN MEXICO. BARD AND TOUCHLESS ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. C. R. BARD, INC. COVINGTON, GA 30014 USA 1-800-526-4455 WWW.BARDMEDICAL.COM PK7635295 02/2013 INSTRUCTIONS FOR USE: PREPARING FOR CATHETERIZATION: 1. OPEN KIT AND REMOVE CONTENTS. 2. THE GLOVES ARE NOT NECESSARY TO MAINTAIN ASEPTIC CONDITIONS DURING THE PROCEDURE. THE GLOVES ARE FOR THE OPERATOR'S PROTECTION. MALE/FEMALE CATHETERIZATION: 1. REMOVE CAP FROM INSERTION TIP WHILE SQUEEZING TABS. SAVE CAP FOR CLOSING THE BAG. 2. SLIDE THE CATHETER HALFWAY INTO THE INSERTION TIP. 3. MALE - PREPARE THE MALE URETHRAL MEATUS AND THE SURROUNDING AREA WITH POVIDONE-IODINE SWABS PROVIDED. FEMALE - PREPARE THE FEMALE URETHRAL MEATUS BY HOLDING THE OUTER LABIA APART AND PREP THE URETHRAL MEATUS AND SURROUNDING AREA WITH POVIDONE IODINE SWABS PROVIDED. 4. MALE - HOLDING THE PENIS, ADVANCE THE INSERTION TIP INTO THE URETHRA NO FURTHER THAN THE FLANGE BASE. FEMALE - SPREAD THE INNER LABIA, ADVANCE THE INSERTION TIP INTO THE URETHRA NO FURTHER THAN THE FLANGE BASE. RELEASE THE INNER LABIA. 5. PLACE YOUR NONDOMINANT HAND ON THE FINGER CONTROL GUIDE TO STABILIZE CATHETER IN URETHRA. WITH YOUR DOMINANT HAND, GRASP CATHETER THROUGH BAG APPROXIMATELY 1" BELOW THE FINGER CONTROL GUIDE AND PUSH CATHETER INTO URETHRA. THE CATHETER SHOULD BE INTRODUCED BY SHORT, REPETITIVE PUSHING MOTIONS. REPEAT MOTIONS UNTIL CATHETER REACHES BLADDER AND URINE STARTS TO FLOW. 6. ALLOW URINE TO FLOW FREELY, MAKING CERTAIN THE CATHETER GUIDE IS ELEVATED AT LEAST 4" ABOVE LOWER PORTION OF THE BAG. ALLOW FLOW UNTIL BLADDER IS EMPTY OR UNTIL BAG IS FILLED. PRECAUTION: IT IS RECOMMENDED THAT THE COLLECTION BAG BE HELD. THE CATHETER COULD POSSIBLY SEPARATE FROM THE COLLECTION BAG WHEN URINE INCREASES WEIGHT OF THE BAG. 7. WITHDRAW THE CATHETER FROM THE URETHRA. REMOVE THE REMAINING PORTION OF THE CATHETER FROM THE COLLECTION BAG BY PULLING IT THROUGH THE INSERTION TIP. NOTE: THE CATHETER IS DESIGNED TO PASS THROUGH THE INSERTION TIP. 8. THE FILLED COLLECTION BAG MAY BE CLOSED BY REPLACING THE CAP OVER THE INSERTION TIP. MAKE SURE THE CAP SNAPS ON SECURELY. SPECIMEN COLLECTION: TO COLLECT A SPECIMEN, OBTAIN A SAMPLE CUP/TUBE AND ALCOHOL WIPE. REMOVE GUIDE TIP BY PULLING TAB(S) UPWARD FROM BAG. WIPE PORT WITH ALCOHOL. POUR SPECIMEN THROUGH PORT AT TOP OF BAG INTO CUP/TUBE. DRAINING BAG: REMOVE INSERTION TIP BY PULLING TAB(S) UPWARD FROM BAG. DRAIN URINE THROUGH PORT AT TOP OF BAG."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER LEAKED FROM THE TOP OF THE BAG, IMMEDIATELY AFTER ALLEGED CORRECT PLACEMENT. NO MEDICAL INTERVENTION WAS REQUIRED.

    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 RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER LEAKED FROM THE TOP OF THE BAG, IMMEDIATELY AFTER ALLEGED CORRECT PLACEMENT. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735099 BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT TOUCHLESS UNISEX CATHETER KIT FCM C.R. BARD, INC. (COVINGTON) -1018233 4A5110 UNK 00801741030574

    Patients

    Seq Age Sex Outcome Treatment
    1