BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® ALL-SILICONE FOLEY CATHETER

    MDR report key: 9917910 · Received April 2, 2020

    Report

    Report Number
    1018233-2020-02323
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 12, 2020
    Report Date
    April 23, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741029752
    PMA / PMN Number
    K040504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿BURST BALLOONS¿ WITH A POTENTIAL ROOT CAUSE OF "HIGH MODULUS LATEX OR NON-UNIFORM THIN SAC AND /OR FINISH DIP COVERAGE". 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: ¿RECOMMENDED INFLATION CAPACITIES 3CC BALLOON: USE 5ML STERILE WATER 5CC BALLOON: USE 10ML STERILE WATER 30CC BALLOON: USE 35ML 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. NOTE: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR 100% SILICONE FOLEY CATHETERS. BARD AND BARDEX ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. 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." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT, AND THE BALLOON WAS "RUPTURED".

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT, AND IT WAS DISCOVERED THAT THE BALLOON HAD "RUPTURED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382468 BARDEX® ALL-SILICONE FOLEY CATHETER SILICONE FOLEY CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 165816 NGDX4417 00801741029752

    Patients

    Seq Age Sex Outcome Treatment
    1