BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP

    MDR report key: 9763992 · Received February 27, 2020

    Report

    Report Number
    1018233-2020-01396
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Report Date
    April 14, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741017827
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED AS THE PROBLEM COULD NOT BE REPRODUCED. A LUBRICATH AMBER FOLEY WAS RETURNED ATTACHED TO URINE METER BAG WITH A STATLOCK. THE CATHETER AND BAG APPEARED TO BE UNUSED. A 10CC LEUR LOCK SYRINGE WAS USED TO INFLATE THE FOLEY CATHETER WITH 10CC OF WATER. THE CATHETER INFLATED WITH NO ISSUES AND THEN PASSIVELY DEFLATED WITHOUT ISSUE. THE DEVICE DID MET SPECIFICATIONS. THE DEVICE WAS BEING USED FOR TREATMENT. A DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED PER THE INVESTIGATION. 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. 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. PK7646070 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. PLEASE CONSULT PRODUCT LABEL AND INSERT FOR ANY INDICATIONS, CONTRAINDICATIONS, HAZARDS, WARNINGS, CAUTIONS AND DIRECTIONS FOR USE." 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER TRIED TO INFLATE THE FOLEY, AND IT INFLATED BELOW THE INFLATION PORT INSTEAD OF THE BLADDER.

    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 USER TRIED TO INFLATE THE FOLEY, AND IT INFLATED BELOW THE INFLATION PORT INSTEAD OF THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230522 BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP COUDE CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 0168L16 NGDV1452 00801741017827

    Patients

    Seq Age Sex Outcome Treatment
    1