BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM COMBI SET FRES2008 POST

    MDR report key: 278103 · Received May 15, 2000

    Report

    Report Number
    8030665-2000-00151
    Event Type
    Injury
    Date Received
    May 15, 2000
    Date of Event
    February 9, 2000
    Report Date
    April 24, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONE OF THREE POSSIBLE PART AND LOT NUMBERS. EITHER 03-222-2 OR 03-2421-0 OR 03-2432-7. THREE EVENTS OCCURRED-TWO AT A FACILITY AND ONE AT ANOTHER FACILITY. DISCONNECTS FROM QUINTON PERMCATH CATHETERS. THIS EVENT OCCURRED 2 HOURS INTO TREATMENT. THE MACHINE DID NOT ALARM. THE CATHETER WAS IMPLANTED IN 99. PT LOST 500-1000ML. OF BLOOD AND WAS HOSPITALIZED BUT DID NOT REQUIRE TRANSFUSION. NO SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM COMBI SET FRES2008 POST BLOODLINE FJK ERIKA DE REYNOSA * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O