BEUDAMED
    FDA Adverse Event Summary report: N

    GRAFTYS DELIVERING GUN

    MDR report key: 3221904 · Received July 11, 2013

    Report

    Report Number
    3006761298-2013-00004
    Date Received
    July 11, 2013
    Date of Event
    November 10, 2010
    Report Date
    July 11, 2013
    Manufacturer
    GRAFTYS
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING AN INSPECTION AT OUR MANUFACTURING SITE IN (B)(4) 2013, INSPECTOR HIGHLIGHTED A WEAKNESS IN OUR VIGILANCE PROCEDURES: WE SHOULD HAVE HAD NOTIFY TO COMPETENT AUTHORITIES SOME OF OUR COMPLAINTS. FOLLOWING THIS NON CONFORMITY, WE REVIEWED OUR VIGILANCE PROCEDURES AND REVIEWED ALL COMPLAINTS RECEIVED SO FAR (SINCE YEAR 2007). WE IDENTIFIED COMPLAINTS THAT NEEDED TO BE NOTIFIED AND WE DID. THAT EXPLAINS THE DELAY BETWEEN US BECOMING AWARE OF THE INCIDENT AND THE DATE WE NOTIFIED IT.

    Description of Event or Problem · 1

    A NON STERILE GRAFTY DELIVERING GUN MAY HAVE BEEN USED BY A SURGEON W/O STERILIZED IT BEFORE USE. THE SURGEON MAY HAVE NOT FOLLOW INSTRUCTIONS FOR USE; HE MAY HAVE NOT STERILIZE IT AS IT IS SPECIFIED IN THE INSTRUCTIONS FOR USE. THE GRAFTY DELIVERING GUN IS AN ACCESSORY THAT FACILITATE THE HANDLING AND INJECTION OF A GRAFTY INJECTABLE PRODUCT. AS CORRECTIVE ACTION WE DECIDED NOT TO SELL NON STERILE GRAFTY DELIVERING GUN ANYMORE. THE CORRECTIVE ACTION HAS BEEN IMPLEMENTED IN AUGUST 2009. WE DON'T HAVE INFO REGARDING THE HEALTHCARE FACILITY. WE DON'T KNOW IF THE RELATED SITUATION OCCURRED AND IF IT OCCURRED WHAT WAS THE OUTCOME ON PT, IF ANY. THIS CASE HAS BEEN NOTIFIED TO THE EUROPEAN COMPETENT AUTHORITY CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319925 GRAFTYS DELIVERING GUN GRAFTYS DELIVERING GUN MQV GRAFTYS NOT COMMUNICATED NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT COMMUNICATED