BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD

    MDR report key: 1041357 · Received May 8, 2008

    Report

    Report Number
    6000002-2008-07131
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 16, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BREAKAGE WAS OBSERVED AT THE JOINT OF THE PORT OF THE INTRODUCER SHEATH AND AT THE SHEATH ITSELF. REPORTEDLY, BLOOD LEAKAGE WAS OBSERVED AND CONTAMINATION WAS FOUND. FOLLOWED UP WITH THE CUSTOMER AND NO ADDITIONAL INFORMATION WAS PROVIDED. NOT RETURNING DEVICE, DISCARDED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD PERCUTANEOUS SHEATH INTRODUCER SET DYB EDWARDS LIFESCIENCES, PR I301BF85H 58458232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other