BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® LUBRICATH® FOLEY CATHETER

    MDR report key: 8675560 · Received June 6, 2019

    Report

    Report Number
    1018233-2019-02979
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Report Date
    June 6, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS INCONCLUSIVE. EVALUATION COULD NOT BE PERFORMED IF ONLY BASED ON THE PHOTO ATTACHED. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THIS REPORTED EVENT IS CONCLUDED AS INCONCLUSIVE DUE TO POOR SAMPLE CONDITION. HOWEVER, THE POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE USER RELATED (EXAMPLE: OVER ASPIRATED, INCORRECT SYRINGE)/ COLLAPSE LUMEN/ SAC CLOSE EYE/ VALVE DAMAGE. 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: WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE BALLOON BURST. 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. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN, PREVENTING BALLOON DEFLATION. IF PERMITTED BY HOSPITAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. IF THIS FAILS, CONTACT AND ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS PLACED IN A SURGICAL PROCEDURE AND THE BALLOON FOR BLADDER ANCHOR WOULD NOT DEFLATE FOR REMOVAL. THE CATHETER 365716 IS A PART OF SURESTEP FOLEY TRAY A800365.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469320 BARD® LUBRICATH® FOLEY CATHETER HYDROGEL CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1