BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 12891870 · Received November 30, 2021

    Report

    Report Number
    12891870
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    September 24, 2021
    Report Date
    October 5, 2021
    Manufacturer
    COVIDIEN
    Product Code
    FKO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HOME PD PATIENT'S TITANIUM ADAPTER CAME OFF OF PD CATHETER WHILE AT HOME. MOM PLACED BLUE CLAMP AND COVERED EXPOSED TIP WITH GAUZE WITH ALCAVIS AND CALLED PD NURSE ON CALL. PATIENT BROUGHT TO FACILITY FOR PD CATHETER REPAIR. PD CATHETER REPAIR DONE BY PD NURSE ON CALL, NEW TITANIUM ADAPTER AND TRANSFER APPLIED. PATIENT DISCHARGED HOME WITH MOM WITH INSTRUCTIONS TO TREAT FOR SYSTEM BREAK. PATIENT WITH SIMILAR INCIDENT TWICE PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792896 ARGYLE CATHETER, PERITONEAL DIALYSIS, SINGLE USE FKO COVIDIEN 8888415604 1933700134

    Patients

    Seq Age Sex Outcome Treatment
    1 1095 DA Male