BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIA® ALL-SILICONE FOLEY CATHETER

    MDR report key: 7798745 · Received August 20, 2018

    Report

    Report Number
    1018233-2018-03672
    Event Type
    Injury
    Date Received
    August 20, 2018
    Report Date
    September 20, 2018
    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
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "BARDIA ALL-SILICONE FOLEY CATHETER 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 PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USE LUER SLIP TIP 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. TO DEFLATE CATHETER BALLOON: GENTLY INSERT 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. BARD C. R. BARD, INC. (B)(4). WWW.BARDMEDICAL.COM BARD AND BARDIA ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN URINARY TRACT INFECTION (UTI) WHILE USING THE FOLEY CATHETER. THE PATIENT STATED THAT SHE WAS PRESCRIBED ANTIBIOTICS TO TREAT THE UTI.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN URINARY TRACT INFECTION (UTI) WHILE USING THE FOLEY CATHETER. THE PATIENT STATED THAT SHE WAS PRESCRIBED ANTIBIOTICS TO TREAT THE UTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638298 BARDIA® ALL-SILICONE FOLEY CATHETER SILICONE CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 806516 UNK 00801741039171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention