BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER INSERTION KIT

    MDR report key: 18324395 · Received December 13, 2023

    Report

    Report Number
    MW5149211
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    December 5, 2023
    Report Date
    December 11, 2023
    Manufacturer
    BARD MEDICAL / C.R. BARD, INC.
    Product Code
    EZC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRIOR TO INSERTION IN A PATIENT, FOLEY CATHETER BALLOON WAS INFLATED. UPON ATTEMPTS TO DEFLATE THE BALLOON, THE BALLOON WOULD NOT DEFLATE AND REMAINED INFLATED. ANOTHER FOLEY KIT WAS PULLED AND THE BALLOON WAS INFLATED AND WOULD NOT DEFLATE. NO PATIENT INVOLVEMENT, ALL EVENTS OCCURRED PRIOR TO INSERTION TO A PATIENT. REF REPORT MW5149212.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59247 FOLEY CATHETER INSERTION KIT CATHETER, COUDE EZC BARD MEDICAL / C.R. BARD, INC. NGHV1794

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown