BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX I.C. COMPLETE CARE TEMPERATURE-SENSING INFECTION CONTROL FOLEY CATHETER

    MDR report key: 14712369 · Received June 15, 2022

    Report

    Report Number
    MW5110355
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    June 12, 2022
    Report Date
    June 13, 2022
    Manufacturer
    BARD MEDICAL /C.R. BARD, INC.
    Product Code
    MJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN PLACED FOLEY PRE PROCEDURE. SURGEON VERIFIED PLACEMENT, BUT NO URINE RETURN. DURING PROCEDURE SURGEON NOTED THE BLADDER WAS FULL. RN REPLACED THE FOLEY CATHETER WITH A NEW FOLEY CATHETER AND THE BLADDER WAS ABLE TO DRAIN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365253 BARDEX I.C. COMPLETE CARE TEMPERATURE-SENSING INFECTION CONTROL FOLEY CATHETER CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES MJC BARD MEDICAL /C.R. BARD, INC. A319416AM

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female