BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD 30" C.I. LINE-DCT 130 - OEM

    MDR report key: 99160 · Received June 16, 1997

    Report

    Report Number
    1317056-1997-00024
    Event Type
    Malfunction
    Date Received
    June 16, 1997
    Date of Event
    May 5, 1997
    Report Date
    June 16, 1997
    Manufacturer
    SCHNEIDER/NAMIC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE UNIT OF A CONTRAST INJECTION LINE WAS RECEIVED IN AN UNSEALED POUCH. THE DEVICE WAS RETURNED, UNUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD 30" C.I. LINE-DCT 130 - OEM CONTRAST INJECTION LINE DXT SCHNEIDER/NAMIC NA 396512

    Patients

    Seq Age Sex Outcome Treatment
    1 NA