BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONVENTED, 2 NU-SITE, 2 ROLLER CLAMPS STRAIGHT SET

    MDR report key: 68395 · Received February 4, 1997

    Report

    Report Number
    1518762-1997-00030
    Event Type
    Malfunction
    Date Received
    February 4, 1997
    Report Date
    February 4, 1997
    Manufacturer
    MEDEX, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE BLUE BALL FAILED TO SEAT ALLOWING AIR TO ENTER THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONVENTED, 2 NU-SITE, 2 ROLLER CLAMPS STRAIGHT SET FLUID ADMINISTRATION SET FPA MEDEX, INC. NA 26K211136,26K211135

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other