BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 1051335 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00013
    Date Received
    May 16, 2008
    Date of Event
    December 13, 2007
    Report Date
    December 20, 2007
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE REPORT: ROOT CAUSE IDENTIFIED: NO. ROOT CAUSE CAN NOT BE DETERMINED SINCE DEFECT WAS NOT CONFIRMED. CONCLUSIONS: DEVICE HISTORY RECORD FOR FINAL PRODUCT WAS REVIEWED AND NO DISCREPANCIES ON IT WERE FOUND. VISUAL AND FUNCTIONAL EVALUATION WERE NOT PERFORMED SINCE THE SAMPLES WERE NOT RECEIVED FOR EVALUATION. DURING THE MANUFACTURING OF THIS PART NUMBER QUALITY DEPARTMENT REALIZED A PRESSURE TEST WITH 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 (PSI) BY THE CUSTOMER. NO DAMAGED TO THE THREADS WERE PERFORMED DURING THIS TEST. CORRECTIVE ACTIONS: NO CORRECTIVE ACTIONS WILL BE APPLIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE SYRINGES USED IN THE ANGIOMAT ILLUMENA INJECTOR BURST AND THE THREADS CAN BE OVER TORQUED (STRIPPED). NO INJURIES REPORTED.

    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 7187115

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK