BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUBRI-SIL

    MDR report key: 5920472 · Received September 1, 2016

    Report

    Report Number
    5920472
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    July 24, 2016
    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

    AN ELDERLY FEMALE WAS ADMITTED FROM ED TO A MEDICAL BED. A URINARY CATHETER WAS PLACED A FEW DAYS AFTER ADMISSION. AFTER THE CATHETER WAS PLACED, SHE DEVELOPED INCREASING OXYGEN NEEDS AND WAS TRANSFERRED TO THE ICU AFTER RECEIVING SEVERAL DOSES OF LASIX. HER URINE OUTPUT WAS NOTED TO BE DECREASED ONCE IN ICU. NURSING NOTED THE CATHETER TO BE OUT OF THE PATIENT BODY WITH BALLOON INTACT, INFLATED AT 7CC. THESE CATHETERS ARE REPLACEMENTS AT OUR FACILITY WHILE OUR STANDARD URINARY CATHETER IS BACKORDERED. A NEW CATHETER WAS INSERTED. OTHER SUCH INCIDENTS HAVE BEEN REPORTED ANECDOTALLY. I 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
    573194 LUBRI-SIL CATHETER, RETENTION TYPE, BALLOON EZK C.R. BARD, INC. NGAT0207

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other NO