BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION BIOLINE 8MM-40CM SUPP PERIPHERAL

    MDR report key: 3912161 · Received May 13, 2014

    Report

    Report Number
    2242352-2014-00561
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    PMA / PMN Number
    K131778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUT 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 HOSPITAL REPORTED THAT THE RINGS NEAR THE DISTAL ANASTOMOSIS WERE LOOSE ANF ELL OFF WITHOUT TOUCHING THEM ON THE FUSION BIOLINE 8MM-40CM SUPP PERIPHERAL GRAFT. THE GRAFT WAS SUTURED IN WITHOUT INCIDENT. THE HOSPITAL REPORTED NO PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285579 FUSION BIOLINE 8MM-40CM SUPP PERIPHERAL VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC M00201503048B0 25089532

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR