BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1051407 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00055
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    August 8, 2007
    Report Date
    August 19, 2007
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT: ROOT CAUSE IDENTIFIED: NO. THE SPECIFIC ROOT CAUSE FOR THIS CRACK IS UNDETERMINED. CONCLUSIONS: DEVICE HISTORY RECORD FOR ASSEMBLE PROCESS WAS REVIEWED AND A NONCONFORMANCE REPORT ORIGINATED DURING THE MFG OF THIS LOT NUMBER. THIS NCR WAS DUE TO THE MACHINE, IN WHICH THE SYRINGES ARE TESTED, HAD AN EXPIRED CALIBRATION. THIS CONDITION DOES NOT AFFECT THE PRODUCT SINCE IT APPLIED MORE PRESSURE THAN 1300 PSI, GIVING SATISFACTORY RESULTS. THIS SYRINGE WAS ASSEMBLED WITH BARREL CAVITY 7 LOT NUMBERS 307995, 309526 AND 309527. IT WAS FOUND THAT A NONCONFORMANCE REPORT FOR LOT NUMBER 309526 WAS REPORTED INDICATING THE MOLDING MACHINE WAS RUNNING OUT OF THE PARAMETERS ESTABLISHED. THERE WAS ALSO A NONCONFORMANCE REPORT FOR LOT NUMBER 309527, IN WHICH IT WAS FOUND THERE WERE FLASHES ON THE INJECTION POINT OF THE SYRINGE. THE SYRINGE WAS MEASURED AT THE CRACK PLACE AND IT IS ACCORDING TO SPECIFICATION. CORRECTIVE ACTIONS: A CAPA HAS BEEN OPENED FOR OPERATE MOLDS OUT OF PARAMETERS. THIS CONDITION REPORTED WILL BE UNDER INVESTIGATION UNTIL ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS: SYRINGE BURST ON FIRST INJECTION. FILLED WITH CONTRAST. IMAGES SHOWS A SMALL SPLIT AT THE CIRCUMFERENCE AT THE TOP OF THE SYRINGE. THE SYRINGE WAS IN A PRESSURE JACKET SLEEVE WHICH PREVENTED ANY SPLATTER OF CONTRAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML (LINDEN LUER) DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900103 7047010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK