BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER

    MDR report key: 8342912 · Received February 15, 2019

    Report

    Report Number
    1018233-2019-00833
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Report Date
    March 20, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741073816
    PMA / PMN Number
    K984136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: ¿BARD® EZ-LOK® SAMPLING PORT, (INDICATED BY THE BLUE STEM IN THE PORT) ACCEPTS LUER LOCK OR SLIP TIP SYRINGES. OCCLUDE DRAINAGE TUBING A MINIMUM OF 3 INCHES BELOW THE SAMPLING PORT BY KINKING THE TUBING UNTIL URINE IS VISIBLE UNDER THE ACCESS SITE. SWAB SURFACE OF BARD® EZ-LOK® SAMPLING PORT WITH ANTISEPTIC WIPE. 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. SLOWLY ASPIRATE URINE SAMPLE INTO SYRINGE AND REMOVE SYRINGE FROM SAMPLE PORT. UNKINK TUBING IF NECESSARY AND TRANSFER URINE SPECIMEN INTO SPECIMEN CUP OR FOLLOW HOSPITAL PROTOCOL. DISCARD SYRINGE ACCORDING TO HOSPITAL PROTOCOL. 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 THE CATHETERS LEAKED. 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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETERS LEAKED. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139346 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER FOLEY CATHETER MJC C.R. BARD, INC. (COVINGTON) -1018233 A303414A NGCT0806 00801741073816

    Patients

    Seq Age Sex Outcome Treatment
    1