BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SL FOLEY SWIVEL SILICONE TRICOT 25BX

    MDR report key: 11826373 · Received May 14, 2021

    Report

    Report Number
    1018233-2021-02804
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 21, 2021
    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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿INAPPROPRIATE SNAP FIT¿. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "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." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STATLOCK DID NOT FIT THE PATIENT¿S FOLEY. CUSTOMER DID NOT HAVE CONFIRMATION OF THE FOLEY SIZE OR BRAND.

    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 STATLOCK DID NOT FIT THE PATIENT¿S FOLEY. CUSTOMER DID NOT HAVE CONFIRMATION OF THE FOLEY SIZE OR BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722909 SL FOLEY SWIVEL SILICONE TRICOT 25BX STATLOCK DEVICE EYJ C.R. BARD, INC. (COVINGTON) -1018233 FOL0102 UNK 00801741076114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other