BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES04

    MDR report key: 6919282 · Received October 5, 2017

    Report

    Report Number
    3007593903-2017-00007
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 6, 2017
    Report Date
    October 5, 2017
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    UDI-DI
    10607151056046
    PMA / PMN Number
    K931338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEFECTIVE POUCH WAS FOUND PRIOR TO USE. NO PATIENT INJURY WAS REPORTED. COMPLAINT WAS NOT CONFIRMED. NO PRODUCT WAS AVAILABLE FOR EVALUATION FOR ES04 WITH STERILE LOT 0617A. PEEL POUCH LABEL AND THE SHELF BOX LABEL ALSO HAVE STATEMENTS THAT READ: DO NOT USE IF PACKAGING IS DAMAGED OR OPENED. QUALITY AWARENESS TRAINING WAS PERFORMED 10-05-2017 FOR ALL APPLICABLE SEALING PERSONNEL OF THE REPORTED COMPLAINT. END USER COULD NOT CONFIRM THE ACTUAL QUANTITY OF UNSEALED POUCHES. THE CARDINAL HEALTH (B)(4) COMPLAINT STATES "THE BAG WAS NOT SEALED" AND SAYS A SAMPLE IS NOT AVAILABLE. REACHED OUT WITH CARDINAL HEALTH (B)(4) AND REPORTING HOSPITAL MULTIPLE TIMES SEEKING VERIFICATION OF THE COMPLAINT OR QUANTITY CONFIRMED, THEY COULD NOT SUPPLY ANY ADDITIONAL INFORMATION. ALSO, REQUESTED INFORMATION ABOUT LOCATING OF THE OPEN SEAL (SUPPLIER SEAL OR BOVIE'S SEAL). NO INFORMATION WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR STERILE LOT 0617A SHOWS A QUANTITY OF (B)(4) PC WAS PACKAGED WITH A 94 PC INSPECTION SAMPLE. NO FAILURES WERE NOTED DURING THE PACKAGING OR INSPECTION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD FOR STERILE LOT 0617A, SHOWS NO FAILURES WERE NOTED DURING THE PACKAGING OR INSPECTION PROCESSES. A REVIEW OF THE RECEIVING INSPECTION HISTORY FILE FOR THE RAW MATERIALS (B)(4) SHOW THIS LOT PASSED THE PULL TEST SAMPLE CHECK PER SP-0735. A. PER SP-0735 THE BURST TEST WAS PERFORMED PER QA-019 BURST TEST PROCEDURE AND FIXTURE F100-2600.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED A BAG THAT WAS NOT SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694830 ES04 EXTENDED BLADE GEI BOVIE MEDICAL CORPORATION 0617A 10607151056046

    Patients

    Seq Age Sex Outcome Treatment
    1 Other