BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 11619197 · Received April 6, 2021

    Report

    Report Number
    11619197
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    February 22, 2021
    Report Date
    March 31, 2021
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INDWELLING URETHRAL CATHETER PLACED IN PATIENT PER ORDERS. 2 HOURS LATER, FOLEY NOTED TO BE OUT OF PATIENT WITH BALLOON PARTIALLY INFLATED. FOLEY BALLOON NOTED TO HAVE A HOLE IN IT UPON FURTHER EXAMINATION. 3 LOT NUMBERS FOR FOLEY CATHETERS ON UNIT: 21ABN465, 20IBD471, 20IBG585.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521323 MEDLINE INDUSTRIES, INC. CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO 21ABN465; 20IBD471; 20IBG585

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA