BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 233137 · Received July 22, 1999

    Report

    Report Number
    8030665-1999-00220
    Event Type
    Injury
    Date Received
    July 22, 1999
    Date of Event
    May 20, 1999
    Report Date
    June 30, 1999
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINIC REPORTS DISCONNECT FROM A CATHETER. ONE OF THREE DISONNECT EVENTS (TWO ADDITIONAL FROM FISTULAS). CLINIC WAS RETRAINED AND NO FURTHER INCIDENCES HAVE OCCURRED. DIRECTOR OF NURSING INDICATES THAT MORE FREQUENT CHECKING IS BEING PERFORMED. ALSO REFER TO PIR #9900940 AND 99001027. THE DISCONNECT RESULTED IN 600CC BLOODLOSS. PTS HEMATOCRIT DROPPED 6 POINTS BUT NO TRANSFUSION WAS NECESSARY. THE PT RECIEVED AN EXTRA DOSE OF EOPGEN. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. PT FEMALE, DOB 12/21/1947, WT 64K. NO LOT NUMBER AND NO SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC BLOODLINE FJK ERIKA DE REYNOSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R