BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF - 150ML BX50

    MDR report key: 1051404 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00027
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    September 21, 2006
    Report Date
    September 22, 2006
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE IDENTIFIED: NO. DEFECT WAS NOT CONFIRMED. CONCLUSIONS: DEVICE HISTORY RECORD WAS REVIEWED AND NO NON CONFORMANCES WERE FOUND DURING MFG PROCESS. CORRECTIVE ACTIONS: NO CORRECTIVE ACTION WAS ASSIGNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT THEY HAVE OPENED A SECOND CASE OF PRODUCT AND STILL THE LUER LOCK NUT IS ALLOWING THE EXTENSION TUBING TO BLOW OFF DURING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF - 150ML BX50 DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900101 6202420

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK