BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6MM 60CM HEMASHIELD MDV

    MDR report key: 3941719 · Received March 5, 2014

    Report

    Report Number
    2242352-2014-00209
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    January 27, 2014
    Report Date
    February 7, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MAL
    PMA / PMN Number
    K954848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. THE DEVICE WAS RETURNED IN ITS ORIGINAL CARTON, ALONG WITH THE GRAFT SIZERS, PATIENT LABELS, AND INSTRUCTIONS FOR USE. BOTH THE INNER AND OUTER BLISTERS REMAINED SEALED. VISUAL INSPECTION DETERMINED THAT THERE WERE MULTIPLE AREAS ON THE DEVICE THAT WERE DARKER IN COLOR THAN OTHER AREAS. THIS TYPE OF DISCOLORATION IS CONSISTENT WITH COLLAGEN COATED GRAFTS AFTER STERILIZATION. THE DISCOLORATION IS COSMETIC IN NATURE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THER WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN AORTA DISSECTION, THE COLLAGEN COATING ON THE HEMASHIELD PLAT WDV GRAFT WAS MELTED (DISCOLORED). A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132715 6MM 60CM HEMASHIELD MDV VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR, LLC M002020952060 12951144

    Patients

    Seq Age Sex Outcome Treatment
    1 NI