BEUDAMED
    FDA Adverse Event Summary report: N

    AVID MEDICAL INC.

    MDR report key: 5250977 · Received November 25, 2015

    Report

    Report Number
    1047429-2015-00005
    Date Received
    November 25, 2015
    Date of Event
    September 22, 2015
    Report Date
    November 25, 2015
    Manufacturer
    AVID MEDICAL INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AVID MEDICAL INC. RECEIVED NOTIFICATION OF A MEDWATCH REPORT ON (B)(6) 2015, THIS COMPLAINT HAD BEEN RECEIVED PREVIOUSLY AND ASSIGNED (B)(4). INVESTIGATION RESULTS: NO SAMPLE OR PHOTO WAS PROVIDED TO AID THE INVESTIGATION. AVID'S PROCESS REQUIRES EACH EMPLOYEE TO DON A HAIR COVER, BEARD COVER (IF APPROPRIATE)AND LAB COAT(FOR CLEAN ROOM ONLY) PRIOR TO ENTERING THE CLEAN ROOM AND PRIOR TO HANDLING RAW MATERIALS OR FINISHED PRODUCT IN THE WAREHOUSE. REUSE OF THE HAIR COVER AND BEARD COVER IS NOT ALLOWED. IF AN EMPLOYEE DOES NOT FOLLOW THE REQUIRED GOWNING PROCEDURES THEY WILL BE DISCIPLINED UP TO AND INCLUDING TERMINATION. IN ADDITION OUR CLEAN ROOM ASSEMBLERS ARE REQUIRED TO CHECK PRODUCT FOR CONTAMINATION AND FOREIGN OBJECTS DURING THE INSPECTION PROCESS, AND DOCUMENTED INTERNAL AUDITS ARE PREFORMED TO ENSURE QSR GUIDELINES ARE FOLLOWED. UNFORTUNATELY, WE ARE UNABLE AT THIS TIME TO DETERMINE HOW AND WHEN THE HAIR WAS INTRODUCED, HOWEVER THE DEFECT WAS NOT DETECTED AND PACKAGED INSIDE THE TRAY. FOLLOW UP ACTIONS: WE HAVE OPENED A FORMAL CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO REVIEW THIS DEFECT MODE AND POSSIBLE ROOT CAUSES. THE CAPA TEAM IDENTIFIED MAJOR ROOT CAUSES AS; POSSIBLE CROSS CONTAMINATION DURING OUR CLEANING PROCESS, QUALITY OF SUPPLIER COMPONENTS AND MATERIAL HANDLING PROCESS. THEREFORE, WE HAVE CONDUCTED IN-SERVICE TRAINING WITH THE PRODUCTION AND WAREHOUSE TEAMS FOR HEIGHTENED AWARENESS AND HAVE IMPLEMENTED ADDITIONAL PROCESS AUDITS TO FOCUS ON THOSE AREAS. THE AVID TEAM WILL CONTINUE TO REVIEW POSSIBLE ROOT CAUSES AND IMPLEMENT APPROPRIATE ACTIONS TO ADDRESS THIS ISSUE. THE DETAILS OF THIS COMPLAINT HAVE BEEN FORWARDED TO THE APPROPRIATE AVID MANAGEMENT TO ENSURE THIS COMPLAINT IS REVIEWED WITH THE APPROPRIATE PERSONNEL. IN ADDITION THIS OCCURRENCE HAS BEEN ENTERED INTO AVID¿S FORMAL COMPLAINT SYSTEM IN WHICH DEFECT TRENDS ARE CLOSELY MONITORED.

    Description of Event or Problem · 1

    HAIR IN TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781505 AVID MEDICAL INC. CUSTOM PROCEDURE TRAY KDD AVID MEDICAL INC. ORHS070-12 1012954

    Patients

    Seq Age Sex Outcome Treatment
    1