BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIA ALL-SILICONE FOLEY CATHETER

    MDR report key: 10508094 · Received September 9, 2020

    Report

    Report Number
    1018233-2020-05769
    Event Type
    Injury
    Date Received
    September 9, 2020
    Report Date
    December 14, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741039171
    PMA / PMN Number
    K040504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE OF THIS FAILURE COULD BE "INADEQUATE STERILIZATION.¿ THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. STERILE: UNLESS PACKAGE IS OPENED OR DAMAGED. WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE SILICONE AND MAY CAUSE BALLOON TO BURST. 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. SINGLE USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. RECOMMENDED INFLATION CAPACITIES 3CC BALLOON: USE 5ML STERILE WATER. 5CC BALLOON: USE 10ML STERILE WATER. 30CC BALLOON: USE 35ML STERILE WATER. DO NOT EXCEED RECOMMENDED CAPACITIES. 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. NOTE: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR 100% SILICONE FOLEY CATHETERS. BARD AND BARDEX ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. 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." H11: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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TWO DIFFERENT PATIENTS DEVELOPED URINARY TRACT INFECTIONS DUE TO FOLEY CATHETER CHANGE AND AN ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DUE TO SUPRAPUBIC CATHETER CHANGE, ALSO ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DURING IN-AND-OUT CATHETERIZATION FOR ROUTINE URINE SAMPLE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED ON 24AUG2020, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS.

    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 TWO DIFFERENT PATIENTS DEVELOPED URINARY TRACT INFECTIONS DUE TO FOLEY CATHETER CHANGE AND AN ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DUE TO SUPRAPUBIC CATHETER CHANGE, ALSO ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DURING IN-AND-OUT CATHETERIZATION FOR ROUTINE URINE SAMPLE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED ON 24AUG2020, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971471 BARDIA ALL-SILICONE FOLEY CATHETER CATHETER INSERTION TRAY EZL C.R. BARD, INC. (COVINGTON) -1018233 806516 UNK 00801741039171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention