BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

    MDR report key: 1051385 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00052
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    September 4, 2007
    Report Date
    September 14, 2007
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT: ROOT CAUSE IDENTIFIED: NO. THIS KIND OF RUPTURE HAS BEEN OBSERVED WHEN THE SYRINGE DOES NOT FIT WELL INTO THE PRESSURE SLEEVE. THIS COULD GENERATE CRACK AT THE TIP OF THE SYRINGE. CONCLUSIONS: DEVICE HISTORY RECORD FOR ASSEMBLE PROCESS WAS REVIEWED AND NO NONCONFORMANCE REPORTS WERE ORIGINATED DURING THE MANUFACTURING OF THIS LOT NUMBER. THIS SYRINGE PART NUMBER 900103 WAS ASSEMBLED WITH BARREL PART NUMBER 900130 LOT NUMBERS 306284, 307994 AND 301930, NO CONCONFORMANCE REPORTS WERE ORIGINATED DURING THE MANUFACTURING OF THESE LOT NUMBERS. THE BARREL WAS MEASURED AND THE OUTSIDE DIAMETER IS OUT OF SPECIFICATION IN THE BOTTOM OF THE BARREL. CORRECTIVE ACTIONS: A CAPA WAS OPENED, AND IT ADDRESSES SYRINGES THAT DO NOT FIT WELL INTO PRESSURE SLEEVE, FOR BARREL 900130 AND 900120.

    Description of Event or Problem · 1

    COVIDIEN GERMANY REPORTS THAT THREE CUSTOMERS HAD PROBLEMS DURING THE USE OF THE SYRINGES: THE SYRINGES BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML (LINDEN LUER) DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 9000103 7012067

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK