BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30" PRESSURE INJECTOR LINE

    MDR report key: 627919 · Received August 10, 2005

    Report

    Report Number
    9616567-2005-00012
    Event Type
    Malfunction
    Date Received
    August 10, 2005
    Report Date
    July 11, 2005
    Manufacturer
    MEDEX
    Product Code
    DYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE LUER LOCK BROKE OFF OF THE TUBING DURING THE SETUP OF THE UNIT. NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30" PRESSURE INJECTOR LINE PRESSURE TUBING DYX MEDEX NA 34I03M009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN