BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 11768930 · Received May 4, 2021

    Report

    Report Number
    11768930
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 23, 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

    TEAR ON PERITONEAL DIALYSIS (PD) CATHETER BY TITANIUM ADAPTER. SUPERFICIAL TEAR NOTED ON THE PERITONEAL DIALYSIS CATHETER BY THE TITANIUM ADAPTER. PD CATHETER WAS REPAIRED AND A NEW TITANIUM ADAPTER AND TRANSFER SET APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667258 ARGYLE CATHETER, PERITONEAL DIALYSIS, SINGLE USE FKO COVIDIEN 8888415604

    Patients

    Seq Age Sex Outcome Treatment
    1 730 DA