BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO AVF SET

    MDR report key: 106067 · Received July 16, 1997

    Report

    Report Number
    1118880-1997-00178
    Event Type
    Malfunction
    Date Received
    July 16, 1997
    Date of Event
    June 18, 1997
    Report Date
    June 18, 1997
    Manufacturer
    TERUMO CORP. ASHITAKA FACTORY
    Product Code
    FIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A MAJOR HOLE WAS FOUND NEAR THE BLOOD LINE CONNECTION. NO BLOOD LEAK AT LOWER PRESSURE BUT A LEAK DID OCCUR AT HIGHER PRESSURE. TUBING (PLASTIC) LOOKS BURNED AND FAILED AT THAT SPOT. MINIMAL BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO AVF SET AV FISTULA NEEDLE SET FIE TERUMO CORP. ASHITAKA FACTORY NA VE0751

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN