BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUETTE CATHETER

    MDR report key: 9592169 · Received January 14, 2020

    Report

    Report Number
    MW5092239
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    November 12, 2019
    Report Date
    January 10, 2020
    Manufacturer
    POIESIS MEDICAL, LLC
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH NEW DUETTE CATHETER, RN ACCESSED URINE SAMPLING PORT TO DRAW URINE SAMPLE, THE PORT BROKE OFF AND URINE LEAKED OUT OF FOLEY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52579 DUETTE CATHETER CATHETER, RETENTION TYPE, BALLOON EZL POIESIS MEDICAL, LLC 00852732004074 20181101

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR