BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZATION DEVICE

    MDR report key: 4927901 · Received July 17, 2015

    Report

    Report Number
    1018233-2015-00228
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 5, 2015
    Report Date
    September 30, 2016
    Manufacturer
    DAVOL SURGICAL INNOVATIONS
    Product Code
    EYJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    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 STATES THE FOLLOWING: "WARNINGS AND PRECAUTIONS: DO NOT USE THE STATLOCK® DEVICE WHERE LOSS OF ADHERENCE COULD OCCUR, SUCH AS WITH A CONFUSED PATIENT, DIAPHORETIC OR NONADHERENT SKIN, OR WHEN THE ACCESS DEVICE IS NOT MONITORED DAILY. OBSERVE UNIVERSAL BLOOD AND BODY FLUID PRECAUTIONS AND INFECTION CONTROL PROCEDURES, DURING APPLICATION AND REMOVAL OF THE STATLOCK® DEVICE. MINIMIZE CATHETER MANIPULATION DURING APPLICATION AND REMOVAL OF THE STATLOCK® DEVICE. DAILY MAINTENANCE: THE STATLOCK® DEVICE SHOULD BE ASSESSED DAILY AND CHANGED WHEN CLINICALLY INDICATED, AT LEAST EVERY SEVEN DAYS. 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. IF SHOWERING/BATHING, COVER WITH PLASTIC WRAP OR WATERPROOF DRESSING. CONDUCT SKIN ASSESSMENT PRIOR TO APPLICATION AND REPEAT DAILY PER FACILITY PROTOCOL. USE CLINICAL JUDGMENT ON THE REMOVAL OF THE STATLOCK® STABILIZATION DEVICE IF THE PATIENT EXPERIENCES ANY FLUID SHIFTS THAT MAY INTERFERE WITH SKIN INTEGRITY. APPLICATION TECHNIQUE PREP PLACE FOLEY CATHETER INTO RETAINER. DIRECTIONAL ARROW SHOULD POINT TOWARDS CATHETER TIP, AND BALLOON INFLATION ARM SHOULD BE NEXT TO THE CLAMP HINGE. CLOSE LID, BEING CAREFUL TO AVOID PINCHING THE CATHETER. 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. AFTER PLACING THE STATLOCK® STABILIZATION DEVICE OFF TO THE SIDE, CLEANSE AND DEGREASE THE SECUREMENT SITE WITH ALCOHOL PER HOSPITAL POLICY. LET SKIN DRY. APPLY SKIN PROTECTANT, IN DIRECTION OF HAIR GROWTH, TO AREA LARGER THAN SECUREMENT SITE. ALLOW TO DRY COMPLETELY (10-15 SECONDS). 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 ALIGN THE STATLOCK® STABILIZATION DEVICE OVER SECUREMENT SITE LEAVING 1 INCH OF CATHETER SLACK. MAKE SURE LEG IS FULLY EXTENDED. 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. (B)(4). 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." H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    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 STATES THE FOLLOWING: "WARNINGS AND PRECAUTIONS: DO NOT USE THE STATLOCK® DEVICE WHERE LOSS OF ADHERENCE COULD OCCUR, SUCH AS WITH A CONFUSED PATIENT, DIAPHORETIC OR NONADHERENT SKIN, OR WHEN THE ACCESS DEVICE IS NOT MONITORED DAILY. OBSERVE UNIVERSAL BLOOD AND BODY FLUID PRECAUTIONS AND INFECTION CONTROL PROCEDURES, DURING APPLICATION AND REMOVAL OF THE STATLOCK® DEVICE. MINIMIZE CATHETER MANIPULATION DURING APPLICATION AND REMOVAL OF THE STATLOCK® DEVICE. DAILY MAINTENANCE: THE STATLOCK® DEVICE SHOULD BE ASSESSED DAILY AND CHANGED WHEN CLINICALLY INDICATED, AT LEAST EVERY SEVEN DAYS. 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. IF SHOWERING/BATHING, COVER WITH PLASTIC WRAP OR WATERPROOF DRESSING. CONDUCT SKIN ASSESSMENT PRIOR TO APPLICATION AND REPEAT DAILY PER FACILITY PROTOCOL. USE CLINICAL JUDGMENT ON THE REMOVAL OF THE STATLOCK® STABILIZATION DEVICE IF THE PATIENT EXPERIENCES ANY FLUID SHIFTS THAT MAY INTERFERE WITH SKIN INTEGRITY. APPLICATION TECHNIQUE: PREP: PLACE FOLEY CATHETER INTO RETAINER. DIRECTIONAL ARROW SHOULD POINT TOWARDS CATHETER TIP, AND BALLOON INFLATION ARM SHOULD BE NEXT TO THE CLAMP HINGE. CLOSE LID, BEING CAREFUL TO AVOID PINCHING THE CATHETER. 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. AFTER PLACING THE STATLOCK® STABILIZATION DEVICE OFF TO THE SIDE, CLEANSE AND DEGREASE THE SECUREMENT SITE WITH ALCOHOL PER HOSPITAL POLICY. LET SKIN DRY. APPLY SKIN PROTECTANT, IN DIRECTION OF HAIR GROWTH, TO AREA LARGER THAN SECUREMENT SITE. ALLOW TO DRY COMPLETELY (10-15 SECONDS). 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: ALIGN THE STATLOCK® STABILIZATION DEVICE OVER SECUREMENT SITE LEAVING 1 INCH OF CATHETER SLACK. MAKE SURE LEG IS FULLY EXTENDED. 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. (B)(4).

    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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STATLOCK SEPARATED FROM THE ADHESIVE BACKING, AS A RESULT, THE DEVICE TRAVELED INTO THE PATIENTS VAGINA. THE PATIENT REQUIRED MANUAL REMOVAL OF THE DEVICE AS IT HAD IMBEDDED INTO THE VAGINAL TISSUE. THE PATIENT SUSTAINED MINIMAL BLEEDING AND IRRITATION DURING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467376 STABILIZATION DEVICE EYJ DAVOL SURGICAL INNOVATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR