BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 MM 15CM HEMASHIELD MDV

    MDR report key: 4092547 · Received June 26, 2014

    Report

    Report Number
    2242352-2014-00736
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MAL
    PMA / PMN Number
    K954848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT THE 8 MM 15CM HEMASHIELD MDV GRAFT ARRIVED AND THE OUTER SHIPPING CONTAINER WAS IN GOOD CONDITION. WHEN IT WAS OPENED THE PACKAGING AS CRUSHED AND THERE WAS A QUESTION OF THE STERILITY OF THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374639 8 MM 15CM HEMASHIELD MDV VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR, LLC M002020951080 25086616

    Patients

    Seq Age Sex Outcome Treatment
    1