BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 11768925 · Received May 4, 2021

    Report

    Report Number
    11768925
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 17, 2021
    Report Date
    April 26, 2021
    Manufacturer
    COVIDIEN
    Product Code
    FKO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PERITONEAL DIALYSIS (PD) TITANIUM ADAPTER CAUSING HOLE IN THE PD CATHETER AND FLUID LEAK. THIS CAN EITHER BE CAUSED BY THE TITANIUM DIGGING INTO THE PD CATHETER OR PD CATHETER IS GETTING BENT AT THIS AREA WHEN SECURED, ALTHOUGH, FROM PAST INCIDENTS, IF IT BECAUSE OF BENDING BY TITANIUM THE TEAR IS USUALLY ABOUT 1-2 CM ABOVE TITANIUM RATHER THAN RIGHT AT THE TITANIUM. MANUFACTURER RESPONSE FOR TITANIUM ADAPTER FOR PD CATHETER, ARGYLE TWO PART TITANIUM LUER ADAPTER (PER SITE REPORTER). MANUFACTURER WAS REQUESTED TO REVIEW THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667254 ARGYLE CATHETER, PERITONEAL DIALYSIS, SINGLE USE FKO COVIDIEN 8888415604

    Patients

    Seq Age Sex Outcome Treatment
    1 4380 DA