BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY

    MDR report key: 8199931 · Received December 27, 2018

    Report

    Report Number
    1018233-2018-06195
    Event Type
    Injury
    Date Received
    December 27, 2018
    Report Date
    January 21, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741073960
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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. ©2017 C. R. BARD, INC. ALL RIGHTS RESERVED. PK7646068 03/2017 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."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FIVE DIFFERENT PATIENTS EXPERIENCED A LEAK WITH THE VENT PORT ON THE FOLEY CATHETER. THE FIVE PATIENTS WERE ALLEGEDLY DIAGNOSED WITH CAUTI'S (CATHETER ASSOCIATED URINARY TRACT INFECTIONS). IT IS UNKNOWN AT THIS TIME OF THE MEDICAL INTERVENTIONS NEEDED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIVE DIFFERENT PATIENTS EXPERIENCED A LEAK WITH THE VENT PORT ON THE FOLEY CATHETER. THE FIVE PATIENTS WERE ALLEGEDLY DIAGNOSED WITH CAUTI'S (CATHETER ASSOCIATED URINARY TRACT INFECTIONS). IT IS UNKNOWN AT THIS TIME OF THE MEDICAL INTERVENTIONS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038920 SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY SURESTEP FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 A800365 NGCU2235 00801741073960

    Patients

    Seq Age Sex Outcome Treatment
    1 Other