BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1435515 · Received November 11, 2008

    Report

    Report Number
    1047429-2008-00002
    Event Type
    Other
    Date Received
    November 11, 2008
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    LRP
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2008 AVID MEDICAL'S SALES REP WAS CONTACTED BY (B)(6) HEALTHCARE AND INFORMED THAT THEY WERE FINDING PARTICULATES IN THE EMESIS BASIN AND WHITE PLASTIC BOWL OF AVID CATALOG #ORHS070-06 LOT# 501867 MANUFACTURED IN JULY, 2008. ON NOVEMBER 6, 2008 AVID RECEIVED MEDWATCH UF/IMPORTER # (B)(4) WHICH STATED "CARDBOARD PIECES FOUND IN STERILE PACK FOR AICD. DEVICE NOT IMPLANTED. NO HARM TO PT." AVID COMPLAINT # (B)(4) WAS ISSUED TO INVESTIGATE ON 08/28/2008. THE INVESTIGATION REVEALED THAT AVID'S CURRENT INSPECTION PROCESS WHICH REQUIRES ASSEMBLERS TO VISUALLY INSPECT COMPONENTS FOR FOREIGN MATERIALS AND WIPE CLEAN WITH ALCOHOL (IF NECESSARY) PRIOR TO PLACING INTO THE TRAY WAS NOT CARRIED OUT PROPERLY. THIS REQUIREMENT IS DOCUMENTED IN AVID'S INSPECTION PROCESS WORK INSTRUCTION, WI INTER 12-01. THE ISSUE OUTLINED IN THIS MED WATCH AND AVID'S COMPLAINT INDICATE A FAILURE TO FOLLOW DOCUMENTED PROCEDURES. THE DHR FOR THE LOT IN QUESTION WAS REVIEWED TO DETERMINE THE PRODUCTION TEAM LEAD RESPONSIBLE FOR THIS BUILD. THE DETAILS OF THE COMPLAINT WERE REVIEWED WITH THE APPROPRIATE PERSONNEL AND TRAINING TO THE INSPECTION PROCESS WI INTER 12-01 CONDUCTED. THIS OCCURRENCE HAS BEEN ENTERED INTO AVID'S FORMAL COMPLAINT SYSTEM IN WHICH DEFECT TRENDS ARE CLOSELY MONITORED, (B)(4)

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LRP AVID MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1