BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY

    MDR report key: 8189538 · Received December 21, 2018

    Report

    Report Number
    1018233-2018-06139
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Report Date
    March 20, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741073922
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED TRAY WITH ORIGINAL PACKAGING PRESENT. IT WAS NOTED THAT THERE WAS A CAP LOOSE IN TRAY AND ONLY A SMALL AMOUNT OF GEL PRESENT IN SYRINGE. A STICKY AMBER COLORED SUBSTANCE WAS ON BOTTOM OF TRAY UNDER THE SWAB. THE SYRINGE CAP NOT BEING SECURELY ATTACHED TO THE SYRINGE BARREL IS OUT OF SPECIFICATION PER. . THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿1. OCCLUDE DRAINAGE TUBING A MINIMUM OF 3 INCHES BELOW THE SAMPLING PORT BY KINKING THE TUBING UNTIL URINE IS VISIBLE UNDER THE ACCESS SITE. 2. SWAB SURFACE OF BARD® EZ-LOK® SAMPLING PORT WITH ANTISEPTIC WIPE. (FIG. 2) 3. USING ASEPTIC TECHNIQUE, POSITION THE SYRINGE IN THE CENTER OF THE SAMPLING PORT. PRESS THE SYRINGE FIRMLY AND TWIST GENTLY TO ACCESS THE SAMPLING PORT. (FIG. 3) 4. SLOWLY ASPIRATE URINE SAMPLE INTO SYRINGE AND REMOVE SYRINGE FROM SAMPLE PORT. 5. UNKINK TUBING IF NECESSARY AND TRANSFER URINE SPECIMEN INTO SPECIMEN CUP OR FOLLOW HOSPITAL PROTOCOL. DISCARD SYRINGE ACCORDING TO HOSPITAL PROTOCOL. 6. FOLLOW ESTABLISHED HOSPITAL PROTOCOL FOR SPECIMEN LABELING AND TRANSPORT TO LAB. BARD, EZ-LOK AND STATLOCK ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2018 C. R. BARD, INC. ALL RIGHTS RESERVED. PK7646068 05/2018 WWW.BARDMEDICAL.COM MANUFACTURER: BARD MEDICAL DIVISION C. R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 USA 1.800.526.4455 STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, EXCEPT FOR ANY INDIVIDUALLY PACKAGED COMPONENTS WITHIN THE TRAY WHICH ARE NOT LABELED AS STERILE. THESE COMPONENTS ARE NOT TERMINALLY STERILIZED. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. SINGLE USE ONLY. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER AND MAY CAUSE BALLOON TO BURST. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICES AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. PLEASE CONSULT PRODUCT LABEL AND INSERT FOR ANY INDICATIONS, CONTRAINDICATIONS, HAZARDS, WARNINGS, CAUTIONS AND DIRECTIONS FOR USE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE SURESTEP FOLEY TRAY, IT WAS FOUND THAT THE CAP CAME OFF OF THE SYRINGE AND AN AMBER COLORED STICKY SUBSTANCE WAS IN THE TRAY. THE TRAY WAS NOT USED AND THE SYRINGE WILL BE RETUNED FOR INVESTIGATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE SURESTEP FOLEY TRAY, IT WAS FOUND THAT THE CAP CAME OFF OF THE SYRINGE AND AN AMBER COLORED STICKY SUBSTANCE WAS IN THE TRAY. THE TRAY WAS NOT USED AND THE SYRINGE WILL BE RETUNED FOR INVESTIGATION. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030857 SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY SYRINGE EZC C.R. BARD, INC. (COVINGTON) -1018233 A800360 UNK 00801741073922

    Patients

    Seq Age Sex Outcome Treatment
    1