BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® I.C. FOLEY CATHETER

    MDR report key: 9145440 · Received October 2, 2019

    Report

    Report Number
    1018233-2019-06151
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 9, 2019
    Report Date
    October 10, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    PMA / PMN Number
    K040658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A 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: ¿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 AN ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL." 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 IDC COULDN¿T BE REMOVED. STAFF HAD TO CUT THE TUBING OF THE CATHETER TO RELEASE FLUID AND REMOVE FROM THE PATIENT. ONCE THE IDC WAS REMOVED, THE BALLOON WAS STILL INFLATED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IDC COULDN¿T BE REMOVED. STAFF HAD TO CUT THE TUBING OF THE CATHETER TO RELEASE FLUID AND REMOVE FROM THE PATIENT. ONCE THE IDC WAS REMOVED, THE BALLOON WAS STILL INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942637 BARDEX® I.C. FOLEY CATHETER FOLEY CATHETER MJC C.R. BARD, INC. (COVINGTON) -1018233 MYDQ1876

    Patients

    Seq Age Sex Outcome Treatment
    1