BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA SILICONE 2-WAY, 5CC FOLEY CATHETER, 14 FR.

    MDR report key: 6490999 · Received April 13, 2017

    Report

    Report Number
    1018233-2017-01810
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 20, 2017
    Report Date
    August 24, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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: ¿DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY BURST BALLOON." (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWICE, WITH TWO DIFFERENT PATIENTS, A LEAKAGE OCCURRED BESIDE THE CATHETER WHEN THEY FILLED UP THE BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWICE, WITH TWO DIFFERENT PATIENTS, A LEAKAGE OCCURRED BESIDE THE KAD WHEN THEY FILLED UP THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270924 BARDIA SILICONE 2-WAY, 5CC FOLEY CATHETER, 14 FR. FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 MYAVR604

    Patients

    Seq Age Sex Outcome Treatment
    1