BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SL FOLEY SWIVEL SILICONE TRICOT 25BX

    MDR report key: 8645620 · Received May 28, 2019

    Report

    Report Number
    1018233-2019-02735
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Report Date
    June 20, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EYJ
    UDI-DI
    00801741076114
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: ¿1. DO NOT USE THE STATLOCK® DEVICE WHERE LOSS OF ADHERENCE COULD OCCUR, SUCH AS WITH A CONFUSED PATIENT, DIAPHORETIC OR NON-ADHERENT SKIN, OR WHEN THE ACCESS DEVICE IS NOT MONITORED DAILY. 2. OBSERVE UNIVERSAL BLOOD AND BODY FLUID PRECAUTIONS AND INFECTION CONTROL PROCEDURES, DURING APPLICATION AND REMOVAL OF THE STATLOCK® DEVICE. 3. MINIMIZE CATHETER MANIPULATION DURING APPLICATION AND REMOVAL OF THE STATLOCK® DEVICE. 4. DAILY MAINTENANCE: A. THE STATLOCK® DEVICE SHOULD BE ASSESSED DAILY AND CHANGED WHEN CLINICALLY INDICATED, AT LEAST EVERY SEVEN DAYS. B. IF PAD BECOMES SOILED, WASH WITH SOAP/WATER, SALINE OR HYDROGEN PEROXIDE. DO NOT USE ALCOHOL OR PREPACKAGED BATHING SYSTEMS, WHICH COULD LEAD TO EARLY LIFTING. C. IF SHOWERING/BATHING, COVER WITH PLASTIC WRAP OR WATERPROOF DRESSING. D. CONDUCT SKIN ASSESSMENT PRIOR TO APPLICATION AND REPEAT DAILY PER FACILITY PROTOCOL. E. USE CLINICAL JUDGMENT ON THE REMOVAL OF THE STATLOCK® STABILIZATION DEVICE IF THE PATIENT EXPERIENCES ANY FLUID SHIFTS THAT MAY INTERFERE WITH SKIN INTEGRITY. THE STATLOCK® STABILIZATION DEVICE SHOULD BE MONITORED DAILY AND REPLACED WHEN CLINICALLY INDICATED, AT LEAST EVERY 7 DAYS. THE CATHETER INSERTION SITE SHOULD BE TREATED PER LOCAL POLICY RECOMMENDATIONS. THE STATLOCK® DEVICE IS CONTRAINDICATED ON PATIENTS WITH KNOWN TAPE AND ADHESIVE ALLERGIES. ALCOHOL AND ACETONE MAY WEAKEN THE ADHESIVE BOND BETWEEN THE STATLOCK® DEVICE PAD AND THE SKIN. CARE SHOULD BE TAKEN WHEN USING THESE SOLUTIONS WHILE PERFORMING CATHETER SITE CARE. PLEASE CONSULT PRODUCT INSERTS AND LABELS FOR ANY INDICATIONS, CONTRAINDICATIONS, HAZARDS, WARNINGS, CAUTIONS AND DIRECTIONS FOR USE. FOR ADDITIONAL INFORMATION ON THE STATLOCK® FOLEY STABILIZATION DEVICE, PLEASE CALL YOUR LOCAL BARD REPRESENTATIVE. © COPYRIGHT 2006-2017 C. R. BARD, INC. BARD AND STATLOCK ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. PROTECTED BY DOMESTIC AND FOREIGN PATENTS AND PATENTS PENDING. PK2405301 05/17 MANUFACTURER: C. R. BARD, INC. COVINGTON, GA 30014 USA 800-526-4455 WWW.BARDMEDICAL.COM ASSEMBLED IN MEXICO INSTRUCTIONS FOR USE FOLEY APPLICATION TECHNIQUE PREP 1. PLACE FOLEY CATHETER INTO RETAINER. DIRECTIONAL ARROW SHOULD POINT TOWARDS CATHETER TIP, AND BALLOON INFLATION ARM SHOULD BE NEXT TO THE CLAMP HINGE. 2. CLOSE LID, BEING CAREFUL TO AVOID PINCHING THE CATHETER. 3. IDENTIFY SECUREMENT SITE BY LAYING THE DEVICE RETAINER ON THE FRONT OF THE THIGH, LEAVING 1 INCH OF CATHETER SLACK BETWEEN INSERTION SITE AND THE STATLOCK® DEVICE RETAINER. 4. AFTER PLACING THE STATLOCK® STABILIZATION DEVICE OFF TO THE SIDE, CLEANSE AND DEGREASE THE SECUREMENT SITE WITH ALCOHOL PER HOSPITAL POLICY. LET SKIN DRY. 5. APPLY SKIN PROTECTANT, IN DIRECTION OF HAIR GROWTH, TO AREA LARGER THAN SECUREMENT SITE. ALLOW TO DRY COMPLETELY (10-15 SECONDS). 6. USING PERMANENT MARKER, WRITE INITIALS AND DATE OF APPLICATION ON THE STATLOCK® DEVICE ANCHOR PAD. NOTE: ALWAYS SECURE CATHETER INTO THE STATLOCK® DEVICE RETAINER BEFORE APPLYING ADHESIVE PAD ON SKIN. PLACE AND PEEL 7. ALIGN THE STATLOCK® STABILIZATION DEVICE OVER SECUREMENT SITE LEAVING 1 INCH OF CATHETER SLACK. MAKE SURE LEG IS FULLY EXTENDED. 8. WHILE HOLDING THE RETAINER TO KEEP THE PAD IN PLACE, PEEL AWAY PAPER BACKING, ONE SIDE AT A TIME AND PLACE TENSION-FREE ON SKIN. REMOVAL TECHNIQUE DISENGAGE 1. OPEN RETAINER BY PRESSING RELEASE BUTTON WITH THUMB, THEN LIFT TO OPEN. 2. REMOVE FOLEY CATHETER FROM THE STATLOCK® DEVICE. DISSOLVE 3. WIPE THE EDGE OF THE PAD USING AT LEAST 5-6 ALCOHOL PADS UNTIL A CORNER LIFTS. THEN CONTINUE TO STROKE UNDERSURFACE OF PAD WITH ALCOHOL TO DISSOLVE ADHESIVE PAD AWAY FROM SKIN. DO NOT PULL OR FORCE PAD TO REMOVE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLASTIC CATHETER HOLDER DISCONNECTED FROM THE ADHESIVE PAD. NO MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASTIC CATHETER HOLDER DISCONNECTED FROM THE ADHESIVE PAD. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441497 SL FOLEY SWIVEL SILICONE TRICOT 25BX STATLOCK DEVICE EYJ C.R. BARD, INC. (COVINGTON) -1018233 JUDNF428 00801741076114

    Patients

    Seq Age Sex Outcome Treatment
    1