BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML BX50

    MDR report key: 1051378 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00037
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    August 11, 2006
    Report Date
    August 11, 2006
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT: ROOT CAUSE IDENTIFIED: ROOT CAUSE HAS NOT BEEN IDENTIFIED. CONCLUSIONS: THE LUER LOCK NUT, ONCE IT IS ASSEMBLED SHOULD NOT DETACH FROM THE BARREL; SYRINGE WAS DESIGNED TO KEEP THE LUER NUT IN POSITION DURING THE FUNCTIONAL TEST. CORRECTIVE ACTIONS: CAPA WAS INITIATED TO ADDRESS THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    COVIDIEN REPORTS VIA E-MAIL THAT CUSTOMER STATES, "THE CONNECTING TUBE CAME LOOSE FROM THE SYRINGE TIP CAUSING THE TIP OF THE SYRINGE TO CRACK." THE PRODUCT WAS BEING USED IN CARDIAC CATH, 10ML/SEC RATE FOR 10ML VOLUME. IT WAS CONNECTED TO A BARD HIGH PRESSURE TUBING (BEING RETURNED FOR INSPECTION) AND A CORDIS 6FR CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML BX50 DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900101 6209130

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK