BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR-CHARGED SINGLE SENSOR CATHETER

    MDR report key: 17078235 · Received June 7, 2023

    Report

    Report Number
    17078235
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 12, 2023
    Report Date
    May 24, 2023
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP
    Product Code
    FEN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS IS A SPECIALTY CATHETER WE USE IN OUR URODYNAMICS ROOM. THE TYPE OF CATHETER IS AN OUTSIDE ORDER CALLED AN AIR-CHARGED SINGLE SENSOR CATHETER THAT IS ORDERED FROM LABORIE MEDICAL TECHNOLOGIES CANADA ULC. THE CATHETER WAS PLACED INTO THE PATIENTS URETHRA AND THEN WE NOTICED THAT NO URINE WAS COMING OUT, JUST AIR. UPON FURTHER INSPECTION, THE CATHETER HAD BEEN SHREDDED AT THE Y-SITE WHERE THE CATHETER MEETS THE PORTION THAT HOOKS TO THE COMPUTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331688 AIR-CHARGED SINGLE SENSOR CATHETER DEVICE, CYSTOMETRIC, HYDRAULIC FEN LABORIE MEDICAL TECHNOLOGIES CORP CAT895 221842

    Patients

    Seq Age Sex Outcome Treatment
    1 730 DA Female