BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUBRI-SIL

    MDR report key: 5920477 · Received September 1, 2016

    Report

    Report Number
    5920477
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    July 24, 2012
    Report Date
    August 25, 2016
    Manufacturer
    C.R. BARD, INC.
    Product Code
    EZK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PREVIOUSLY PLACED URINARY CATHETER FELL OUT OF A SEDATED MALE PATIENT IN THE ICU. THE CATHETER HAD BEEN INSERTED THE DAY BEFORE IN THE ED WHEN THE PT WAS INTUBATED NASALLY FOR ANGIO-EDEMA. WHEN THE ICU NURSE CHECKED THE CATHETER THAT CAME OUT OF THE PATIENT, SHE FOUND THAT THE BALLOON DID INFLATE. THE NURSE BELIEVES THAT THE BALLOON MUST HAVE BEEN MUST INFLATED BECAUSE THERE WAS SOME WATER IN THE BALLOON WHEN INFLATED WITH AIR. A NEW CATHETER WAS INSERTED. WE USED THIS SUBSTITUTE PRODUCT FOR ABOUT TWO WEEKS. WE HAVE USED ABOUT 20 KITS. THEY WERE STORED IN THE CLEAN SUPPLY ROOM AS WELL AS IN THE STAT-ROOM ON THE SECOND FLOOR. OTHER SUCH INCIDENTS HAVE BEEN REPORTED ANECDOTALLY. WE HAVE NOT BEEN ABLE TO CONFIRM ANY DETAILS OF A 3RD AND POSSIBLY 4TH SUCH EVENT, BUT THIS IS A RECURRING PROBLEM AT OUR FACILITY WITH THESE REPLACEMENT CATHETERS. MANUFACTURER RESPONSE FOR URINARY CATHETER, TRAY FOLEY 16FR W/URIMETER (PER SITE REPORTER): THE COMPANY HAS ASKED FOR ADDITIONAL INFORMATION AND I WILL CONTACT THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571722 LUBRI-SIL CATHETER, RETENTION TYPE, BALLOON EZK C.R. BARD, INC. NGAS1472

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NO