BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150 ML BX 50

    MDR report key: 1051376 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00031
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    October 13, 2006
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 DURING VASCULAR PROCEDURES, THE LUER NUT EITHER BLOWS OFF THE SYRINGE OR THE COOK CONNECTION TUBING IS BLOWN OFF THE TIP OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150 ML BX 50 DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900101 6202420

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK