BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASE-150ML SYRINGE W/HANDIFIL

    MDR report key: 1278943 · Received January 7, 2009

    Report

    Report Number
    1518293-2008-00071
    Event Type
    Malfunction
    Date Received
    January 7, 2009
    Date of Event
    August 12, 2004
    Report Date
    August 30, 2004
    Manufacturer
    LIEBEL - FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REPORT: CONCLUSIONS/CORRECTIVE ACTIONS: SINCE THERE IS NO SAMPLE AVAILABLE FOR EVALUATION, CORRECTIVE ACTIONS CANNOT BE TAKEN FROM THIS INVESTIGATION. DEVICE HISTORY RECORD DEOS NOT HAS EVIDENCE OF ANY ABNORMAL CONDITIONS WITHIN THE MANUFACTURING PROCESS. NONE OF THE 16 INSPECTED UNITS SHOWED THE COMPLAINT CONDITION REPORTED, UPON THESE RESULTS, THE PRODUCT WAS RELEASED FOR DISTRIBUTION. COMPLAINT WILL BE REOPENED IF THE SAMPLES ARE RECEIVED.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTS THAT CUSTOMER STATES, "FILLING A SYRINGE OF CONTRAST MEDIA, A FILAMENTOUS FOREIGN OBJECT IS FOUND IN THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASE-150ML SYRINGE W/HANDIFIL DISPOSABLE SYRINGE, EMPTY DXT LIEBEL - FLARSHEIM CO. 600269 3241060

    Patients

    Seq Age Sex Outcome Treatment
    1