BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX 2-WAY 5CC ALL-SILICON FOLEY CATHETER

    MDR report key: 2993877 · Received March 1, 2013

    Report

    Report Number
    1018233-2013-00676
    Event Type
    Injury
    Date Received
    March 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DESCRIBED COMPLAINT COULD NOT BE CONFIRMED AS THE REPORTED PROBLEM COULD NOT BE REPRODUCED. A VISUAL EVALUATION OF RETURNED CATHETER DID NOT NOTE BALLOON CUFF ROLL. FUNCTIONAL EVALUATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM THE REPORTED PROBLEM AS IT COULD NOT BE REPRODUCED. DIMENSIONS TAKEN OF THE BALLOON ACTIVE LENGTH FOUND IT TO BE WITHIN SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD OF THE INVOLVED LOT NGWJ3689 DID NOT SHOW ANY MANUFACTURING DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE LABELING AND INSTRUCTIONS FOR USE (IFU) WERE FOUND TO BE ADEQUATE. THE IFU INFORMS THE USER: 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 ASPIRE 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. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10CC OF WATER WAS DRAINED FROM THE BALLOON. AN ATTEMPT TO REMOVE THE CATHETER WAS UNSUCCESSFUL AS IT GOT STUCK AND THE PATIENT EXPERIENCED PAIN. THE DOCTOR WAS BROUGHT TO THE BEDSIDE AND ATTEMPTED TO REMOVE THE CATHETER WITHOUT SUCCESS. FOLLOWING THIS ATTEMPT, THE PATIENT WAS GIVEN VERSED, AND LIDOCAINE JELLY WAS PLACED AROUND THE CATHETER WHICH RESULTED IN SUCCESSFUL REMOVAL BY THE DOCTOR. THE PATIENT DID EXPERIENCE SOME PAIN WITH THE REMOVAL. THE CUSTOMER FURTHER REPORTED THAT UPON REMOVAL THE BALLOON WAS NOTED TO HAVE A LARGE RIDGE AROUND THE RIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89482 BARDEX 2-WAY 5CC ALL-SILICON FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGWJ3689

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention