BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6950776 · Received October 16, 2017

    Report

    Report Number
    1018233-2017-05271
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    August 8, 2017
    Report Date
    October 16, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    PMA / PMN Number
    K984136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. RECEIVED 1 SILICONE CATHETER. PER VISUAL INSPECTION, A CUT TO 0.5¿ FROM THE BIFURCATION ON THE INFLATION LUMEN WAS FOUND. DURING FUNCTIONAL EVALUATION, WATER WAS INJECTED BY INFLATION LUMEN, AND LEAKAGE WAS NOTED BY THE CUT BELOW THE BIFURCATION AREA ON THE INFLATION LUMEN. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "STERILE: UNLESS PACKAGE IS OPENED OR DAMAGED. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLATUM BASE. THEY WILL DAMAGE SILICONE AND MAY CAUSE THE 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. NOTE: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR 100% SILICONE FOLEY CATHETERS. 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. 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. RECOMMENDED INFLATION CAPACITIES 3CC BALLOON: USE 5CC STERILE WATER 5CC BALLOON: USE 10CC STERILE WATER 30CC BALLOON:USE 35CC 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. BARD IS A REGISTERED TRADEMARK OF C. R. BARD, INC. OR AN AFFILIATE. LUBRI-SIL IS A TRADEMARK OF C. R. BARD, INC. OR AN AFFILIATE. *BACTI-GUARD® SILVER TECHNOLOGY IS LICENSED FROM ADHESIVE TECHNOLOGY (INTERNATIONAL) LICENSING B.V. 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." (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER FOUND WATER LEAKAGE NEAR THE VALVE WHILE TRYING TO INSERT THE CATHETER INTO THE PATIENT FOR URINE DRAINAGE AND TEMPERATURE MANAGEMENT. DURING THE EVALUATION, THE USER OBSERVED THAT THE SHAFT HAD A CUT ON THE DRAINAGE LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732966 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER FOLEY CATHETER (SILICONE) MJC C.R. BARD, INC. (COVINGTON) -1018233 NGAQ2800

    Patients

    Seq Age Sex Outcome Treatment
    1