BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20371455 · Received October 4, 2024

    Report

    Report Number
    1018233-2024-06222
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    July 1, 2024
    Report Date
    January 17, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741025341
    PMA / PMN Number
    K040504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED LUBRI-SIL ALL SILICONE FOLEY CATHETER WITH LABEL ATTACHED TO THE DRAINAGE BAG. VISUAL INSPECTION OF THE SAMPLE NOTED 1 TWO-WAY FOLEY CATHETER ATTACHED TO THE DRAINAGE BAG WITH BALLOON RUPTURE MEASURING (0.2700") WITH NO MISSING PIECES WERE NOTED. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLATUM BASE. THEY WILL DAMAGE SILICONE AND MAY CAUSE THE BALLOON TO BURST. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. CAUTION: DO NOT ASPIRATE URINE THROUGH DRAINAGE FUNNEL WALL. STORAGE: STORE CATHETERS 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 IS OPENED OR DAMAGED. SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. CATHETERS SHOULD BE REPLACED IN ACCORDANCE WITH THE CDC GUIDELINE ¿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. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A SYRINGE IN 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 INFLATION CAPACITIES 5CC BALLOON: USE 10CC STERILE WATER 30CC BALLOON: USE 35CC STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES.¿ UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 FOLEY CATHETER WAS PLACED IN THE OPERATING ROOM PRIOR TO SURGERY BALLOON WAS INFLATED WITH STERILE WATER. AFTER INSERTION, FOLEY WAS BEING POSITIONED AND CAME OUT ON POSITIONING. THE BALLOON WAS TESTED AFTER REMOVAL FROM THE PATIENT AND THE BALLOON WAS BROKEN OR NOT INTACT. NURSE CIRCULATOR NOTIFIED THE OPERATING ROOM CHARGE NURSE AND MANAGER THAT THE FOLEY BALLOON EITHER BROKE DURING INFLATION OR WAS ALREADY NOT INTACT PRIOR TO INFLATION. CHARGE AND MANAGER TOLD THE NURSE CIRCULATOR TO PROCEED WITH PLACING A NEW FOLEY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLEY CATHETER WAS PLACED IN THE OPERATING ROOM PRIOR TO SURGERY BALLOON WAS INFLATED WITH STERILE WATER. AFTER INSERTION, FOLEY WAS BEING POSITIONED AND CAME OUT ON POSITIONING. THE BALLOON WAS TESTED AFTER REMOVAL FROM THE PATIENT AND THE BALLOON WAS BROKEN OR NOT INTACT. NURSE CIRCULATOR NOTIFIED THE OPERATING ROOM CHARGE NURSE AND MANAGER THAT THE FOLEY BALLOON EITHER BROKE DURING INFLATION OR WAS ALREADY NOT INTACT PRIOR TO INFLATION. CHARGE AND MANAGER TOLD THE NURSE CIRCULATOR TO PROCEED WITH PLACING A NEW FOLEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691900 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER SILICONE FOLEY CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 NGJQ3300 00801741025341

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other