BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUINTON INSTRUMENT CO.

    MDR report key: 150104 · Received February 20, 1998

    Report

    Report Number
    MW1013025
    Event Type
    Malfunction
    Date Received
    February 20, 1998
    Date of Event
    January 22, 1998
    Report Date
    February 13, 1998
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN WAS INSERTING THE SHEATH, NOTICED SHARP OVAL ON END (NOT SMOOTH). WHITE PORTION OF TUBING SPLIT LENGTH OF TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUINTON INSTRUMENT CO. INTRODUCER SET DYB QUINTON INSTRUMENT CO. #15544-013 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR