BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO AVF SET

    MDR report key: 116366 · Received August 30, 1997

    Report

    Report Number
    1118880-1997-00223
    Event Type
    Injury
    Date Received
    August 30, 1997
    Date of Event
    August 25, 1997
    Report Date
    August 27, 1997
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONNECTOR CAME UNATTACHED FROM THE VENOUS BLOOD LINE. PT LOST 350 CC OF BLOOD. THE CHARGE NURSE WITNESSED THE INCIDENT, AND CONFIRMED THAT THE PT IS OKAY. PT WAS SEVERAL HOURS INTO TREATMENT WHEN THIS OCCURRED. THE INVOLVED SAMPLE WAS DESTROYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO AVF SET AV FISTULA NEEDLE SET FIE TERUMO MEDICAL CORP. NA VH2851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention