BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 PRONG ECO SET W/2 PREFILLED CONNECTOR

    MDR report key: 112378 · Received August 6, 1997

    Report

    Report Number
    2242621-1997-90001
    Event Type
    Injury
    Date Received
    August 6, 1997
    Manufacturer
    FRESENIUS USA
    Product Code
    KPF
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    HOME PT REPORTED THAT THE ECO SETS LEAKED WHERE THE THREE LINES JOINED THE ONE LINE. NO PT ILL EFFECTS. PT PLACED ON ANTIBIOTICS PROPHYLACTICALLY. PT DID NOT DEVELOP PERITONITIS. SAMPLE IS AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 PRONG ECO SET W/2 PREFILLED CONNECTOR * KPF FRESENIUS USA 6587133 70-130-62

    Patients

    Seq Age Sex Outcome Treatment
    1 *