BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8152885 · Received December 11, 2018

    Report

    Report Number
    1018233-2018-05983
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Report Date
    March 28, 2019
    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
    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 WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿UTIS ACCOUNT FOR 40% OF NOSOCOMIAL INFECTIONS1 C. R. BARD, INC. COVINGTON, GA 30014 USA 1-800-526-4455 WWW.BARDMEDICAL.COM IN VITRO TESTING OF BACTERIAL ADHERENCE DEMONSTRATES THAT THE LUBRI-SIL I.C. FOLEY CATHETER COATING REDUCES ADHESION OF THE BACTERIA MOST COMMONLY ASSOCIATED WITH NOSOCOMIAL UTIS² BARD INFECTION CONTROL SYSTEM PK7609286 02/2008 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. RECOMMENDED INFLATION CAPACITIES 5CC BALLOON: USE 10CC STERILE WATER 30CC BALLOON: USE 35CC STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES. BARD AND LUBRI-SIL ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. *BACTI-GUARD® SILVER ALLOY COATING IS LICENSED FROM BACTIGUARD AB. BACTI-GUARD IS A REGISTERED TRADEMARK OF BACTIGUARD AB. U.S. PATENT NOS. 5,179,174; 5,320,908; 5,395,651; 5,747,178; 5,965,204; AND PATENTS PENDING CANADIAN PATENT NO. 2,016,081; AUSTRALIAN PATENT NO. 642,872 ©2007 C. R. BARD, INC. ALL RIGHTS RESERVED. 1SALGADO CD, KARCHMER TB, FARR BM. PREVENTION OF CATHETER-ASSOCIATED URINARY TRACT INFECTIONS. PREVENTION AND CONTROL OF NOSOCOMIAL INFECTIONS, 4TH ED. WENZEL RP, EDITOR. LIPPINCOTT WILLIAMS AND WILKINS, PHILADELPHIA, 2003. ²AHEARN D.G., ET AL: EFFECTS OF HYDROGEL/SILVER COATINGS ON IN VITRO ADHESION TO CATHETERS OF BACTERIA ASSOCIATED WITH URINARY TRACT INFECTIONS. CURRENT MICROBIOLOGY, 2000, 41:120-125. 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. PEEL TO OPEN INFECTION CONTROL ALL-SILICONE FOLEY CATHETER 100% LATEX-FREE 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. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLATUM BASE. THEY WILL DAMAGE SILICONE AND MAY CAUSE THE BALLOON TO BURST. 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. VALVE TYPE: USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. LUBRI-SIL® I.C. ® WITH BARD® HYDROGEL AND BACTI-GUARD®* SILVER ALLOY COATING ANTI-MICROBIAL ALL-SILICONE FOLEY CATHETER"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY BALLOON PREMATURELY DEFLATED AND FELL OUT OF THE PATIENT. THE CATHETER WAS INSERTED FOR APPROXIMATELY THIRTY MINUTES. NO MEDICAL INTERVENTION WAS REPORTED.

    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 FOLEY BALLOON PREMATURELY DEFLATED AND FELL OUT OF THE PATIENT. THE CATHETER WAS INSERTED FOR APPROXIMATELY THIRTY MINUTES. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989445 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER COUDE FOLEY CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 0170SI16 UNK 00801741025341

    Patients

    Seq Age Sex Outcome Treatment
    1