BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAMIC/VA

    MDR report key: 1021611 · Received March 26, 2008

    Report

    Report Number
    1317056-2008-00020
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    NAMIC/VA
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS PERFORMED ON THE REPORTED LOT NUMBER. NO QUALITY OR MFG ISSUES WERE NOTED. A REVIEW OF THE COMPLAINT REPORT FOR THE PREVIOUS 15 MONTHS FOR THE DEFECT CODE OF "AIR BUBBLES" DID NOT SHOW AN ADVERSE TREND FOR THIS PRODUCT FAMILY. THE RETURNED MANIFOLD WAS VISUALLY INSPECTED AND APPEARED TO BE ASSEMBLED PER SPECIFICATION. THE SAMPLE WAS THEN LEAK TESTED PER PROCEDURE AND NO LEAKAGE/PRESSURE DECAY WAS OBSERVED. EACH PORT OF THE MANIFOLD WAS TESTED SEPARATELY FOUND TO BE WITHIN SPECIFICATION. AS THE RETURNED SAMPLE FUNCTIONED AS INTENDED, THE COMPLAINT IS UNABLE TO BE CONFIRMED AND THE ROOT CAUSE UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    AS REPORTED BY CUSTOMER, DURING A PCI PROCEDURE, AIR WAS ENTERING THE SYSTEM BECAUSE OF A LEAK AT ONE OF THE MANIFOLD HANDLES. NO AIR WAS INJECTED AND THERE WERE NO PT COMPLICATIONS. THE PROCEDURE WAS COMPLETED USING ANOTHER, SIMILAR MANIFOLD. THE USED DEVICE HAS BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAMIC/VA MANIFOLD DTL NAMIC/VA NA 2044259

    Patients

    Seq Age Sex Outcome Treatment
    1