BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17434366 · Received August 1, 2023

    Report

    Report Number
    1018233-2023-05651
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 10, 2023
    Report Date
    July 13, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741025235
    PMA / PMN Number
    K040504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "INCORRECT BALLOON DESIGN (BALLOON WALL THICKNESS EXCESSIVE)". IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. 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: "LUBRI-SIL® I.C. ANTI-MICROBIAL ALL-SILICONE FOLEY CATHETER WITH BARD® HYDROGEL AND BACTI-GUARD® SILVER ALLOY COATING INFECTION CONTROL ALL-SILICONE FOLEY CATHETER 100% LATEX FREE. WARNING: ON CATHETERS, DO NOT USE OINTMENT OR LUBRICANT. THEY CAN DAMAGE THE SILICONE AND MAY CAUSING THE BALLOON TO BURST. WARNING: AFTER USE, THIS PRODUCT MAY CONTAIN POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. CAUTION: FEDERAL (U.S.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. CAUTION: DO NOT ASPIRATE URINE THROUGH THE DRAINAGE FUNNEL WALL. STORAGE: STORE THE CATHETER AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. NOTE: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR 100% SILICONE FOLEY CATHETERS. STERILE UNLESS PACKAGE HAS BEEN OPENED OR DAMAGED. SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RE-STERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USE LUER SLIDE SYRINGES. DO NOT USE NEEDLES. CATHETERS SHOULD BE REPLACED IN ACCORDANCE WITH THE CDC GUIDELINES ¿GUIDELINE FOR PREVENTION OF CATHETER-ASSOCIATED URINARY TRACT INFECTION¿. AT THE ONSET OR FIRST SIGNS OF A URINARY TRACT INFECTION, CATHETER ENCRUSTATION, OR ANY OTHER CATHETER-RELATED ADVERSE EFFECT, THE CATHETER SHOULD BE REPLACED. PREVENTING CATHETER-RELATED TO DEFLATE THE CATHETER BALLOON: GENTLY INSERT THE SYRINGE INTO THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. ALLOW THE BALLOON TO DEFLATE SLOWLY ON ITS OWN. DO NOT ASPIRATE OR MANUALLY ACCELERATE THE DEFLATION OF THE BALLOON. IF PERMITTED BY HOSPITAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. IF THIS FAILS, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. RECOMMENDED INFLATABLE CAPACITIES 5CC BALLOONS: USE 10CC STERILE WATER 30CC BALLOON: USE 35CC STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITY." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 THESE FOLEY CATHETER CAUSED BLEEDING AND WERE DIFFICULT TO REMOVE. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634737 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER SILICONE FOLEY CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741025235

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other