BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUBRI-SIL I.C. COMPLETE CARE TEMPERATURE-SENSING

    MDR report key: 12099336 · Received June 30, 2021

    Report

    Report Number
    MW5102221
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 24, 2021
    Report Date
    June 28, 2021
    Manufacturer
    BARD MEDICAL / C.R. BARD, INC.
    Product Code
    MJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    URINARY CATHETER IN LUBRI-SIL I.C. COMPLETE CARE TEMPERATURE-SENSING FOLEY CATHETER TRAY WAS DISCOLORED (TAN COLORED). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989626 LUBRI-SIL I.C. COMPLETE CARE TEMPERATURE-SENSING CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES MJC BARD MEDICAL / C.R. BARD, INC. 319516AM NGEX5079

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR