BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

    MDR report key: 8312562 · Received February 6, 2019

    Report

    Report Number
    1018233-2019-00689
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    January 14, 2019
    Report Date
    April 23, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741034169
    PMA / PMN Number
    K040504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 (FIG. 1A) OR SLIP TIP SYRINGES (FIG. 1B). 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. THE SYRINGE SHOULD BE HELD PERPENDICULAR TO THE SURFACE OF THE SAMPLING PORT (AT APPROXIMATELY 80 - 100 DEGREE ANGLE). 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. (FIG. 4) 5. UNKINK TUBING 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. WWW.BARDMEDICAL.COM MANUFACTURER: C. R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 USA 1.800.526.4455 STERILIZED USING ETHYLENE OXIDE 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 RE-STERILIZE. 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 WHEN THE FOLEY CATHETER WAS INSERTED, ONLY 1CC OF WATER WOULD GO INTO THE BALLOON. WHEN THE NURSE ATTEMPTED TO REMOVE THE 1CC OF WATER, THEY WERE UNABLE TO DO SO. TWO DIFFERENT NURSES ATTEMPTED TO INFLATE AND DEFLATE THE BALLOON BUT WERE UNSUCCESSFUL. THE FOLEY WAS REMOVED SLOWLY WITH A SMALL AMOUNT OF RESISTANCE DUE TO THE 1CC OF WATER STILL PRESENT IN THE BALLOON. ANOTHER FOLEY CATHETER WAS INSERTED SUCCESSFULLY INTO THE PATIENT. THERE WAS URINE RETURNED AND A SMALL AMOUNT OF BLOOD IN THE DRAINAGE BAG.

    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 WHEN THE FOLEY CATHETER WAS INSERTED, ONLY 1CC OF WATER WOULD GO INTO THE BALLOON. WHEN THE NURSE ATTEMPTED TO REMOVE THE 1CC OF WATER, THEY WERE UNABLE TO DO SO. TWO DIFFERENT NURSES ATTEMPTED TO INFLATE AND DEFLATE THE BALLOON BUT WERE UNSUCCESSFUL. THE FOLEY WAS REMOVED SLOWLY WITH A SMALL AMOUNT OF RESISTANCE DUE TO THE 1CC OF WATER STILL PRESENT IN THE BALLOON. ANOTHER FOLEY CATHETER WAS INSERTED SUCCESSFULLY INTO THE PATIENT. THERE WAS URINE RETURNED AND A SMALL AMOUNT OF BLOOD IN THE DRAINAGE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106775 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER FOLEY CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 175816 NGCV3148 00801741034169

    Patients

    Seq Age Sex Outcome Treatment
    1