BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8216763 · Received January 4, 2019

    Report

    Report Number
    1018233-2019-00083
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    August 29, 2018
    Report Date
    January 4, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741039843
    PMA / PMN Number
    K070582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED CATHETER WITH A LARGE TEAR IN THE SILICONE 2.4565" FROM THE CATHETER TIP. THE TEAR TRAVELED AROUND MOST OF THE CATHETER WITH BOTH ENDS OF THE TORN CATHETER BARELY STAYING TOGETHER. THE THERMISTOR WIRE WAS NOT SEVERED, BUT WAS EXPOSED DUE TO A CUT THERMISTOR LUMEN WITH THE WIRE INSULATION TORN AS WELL. THE INFLATION AND DRAINAGE LUMEN WERE SEVERED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿DO NOT STRETCH CATHETER. THIS WILL CAUSE REPOSITIONING OF PROBE. DO NOT USE STYLET. THIS WILL CAUSE STRETCHING OF CATHETER. RECOMMENDED INFLATION CAPACITIES: 8 FR. AND 10 FR. (3CC BALLOON): USE 3.5CC STERILE WATER. 12 FR. (5CC BALLOON): USE 5.5CC STERILE WATER. 14 FR. AND LARGER (5CC BALLOON): USE 10CC STERILE WATER. DO NOT EXCEED RECOMMENDED CAPACITIES. BARD, LUBRI-SIL , AND THE I.C. LOGO 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. (B)(4), AND PATENTS PENDING (B)(4). PATENT NO (B)(4); (B)(4) PATENT NO. (B)(4). ©2006 C. R. BARD, INC. ALL RIGHTS RESERVED. (B)(4) 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. PK7602977 12/2006 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. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER SLIP TIP 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. NOTE: COMPATIBLE ONLY WITH THE BARD CRITICORE MONITOR, BARD UROTRACK 224 MONITOR, AND OTHER 400-SERIES TEMPERATURE MONITORS. INTERCHANGEABILITY + 0.2OC AT 37OC. PEEL TO OPEN 100% LATEX-FREE TEMPERATURE-SENSING 400-SERIES FOLEY CATHETER CATHETER SHAFT MADE OF 100% SILICONE ELASTOMER 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"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS WATER LEAKAGE FROM AN UNKNOWN POINT ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10573 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER FOLEY CATHETER(SILICONE) MJC C.R. BARD, INC. (COVINGTON) -1018233 119314 NGBZ0531 00801741039843

    Patients

    Seq Age Sex Outcome Treatment
    1