BEUDAMED
    FDA Adverse Event Other Summary report: N

    NV ANESTHESIA I.V. SET

    MDR report key: 68290 · Received February 5, 1997

    Report

    Report Number
    57302-1997-00004
    Event Type
    Other
    Date Received
    February 5, 1997
    Report Date
    January 6, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE BACKCHECK VALVED FAILED DURING CLINICAL USE OF THE DEVICE. NO MEDICAL INTERVENTION WAS REQUIRED AND NO PATIENT ILL EFFECTS WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NV ANESTHESIA I.V. SET ADMINISTRATION SET FPA ABBOTT LABORATORIES NA 21-062-NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other