BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1051387 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00056
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    September 5, 2007
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT: ROOT CAUSE IDENTIFIED: NO ROOT CAUSE CAN NOT BE DETERMINED SINCE DEFECT WAS NOT CONFIRMED. THE SAMPLE DOES NOT SHOW ANY VISUAL PROBLEM. CONCLUSIONS: DEVICE HISTORY RECORD FOR FINAL PRODUCT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE HISTORY RECORD FROM MOLDING AREA FOR LOCK NUT P/N 900135 LOT NUMBER 330451 WAS REVIEWED AND THERE ARE NO NONCONFORMANCE REPORTS. PRESSURE TEST WAS NOT PERFORMED SINCE THIS SAMPLE IS NOT IN A CONDITION TO BE FUNCTIONALLY EVALUATED. DURING THE MANUFACTURING OF THIS PART NUMBER QUALITY DEPT PERFORMED A PRESSURE TEST WITH 1300 PSI ACCORDING TO THE INSTRUCTION NUMBER AND ALL THE SAMPLES PASS THIS TEST. THIS PRESSURE APPLIED AT 1300 PSI IS GREATER THAN THE PRESSURE USED (75-1200 PSI) BY THE CUSTOMER. CORRECTIVE ACTIONS: NO CORRECTIVE ACTIONS WILL BE APPLIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING A CARDIAC CATH PROCEDURE, CONTRAST SPRAYED OUT THE TIP OF THE SYRINGE CONNECTION. NO PT OR STAFF INJURY. SYRINGE WAS CONNECTED TO A NAMIC HP TUBE, WHICH WAS CONNECTED TO A BOSTON SCIENTIFIC 5FR, 110CM PIGTAIL CATHETER. INJECTION PROTOCOL USED WAS 12ML PER SEC FOR VOLUME 30ML VOLUME.

    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 7173021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK