BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN SURGICAL MARKER

    MDR report key: 3809859 · Received May 14, 2014

    Report

    Report Number
    1226348-2014-11590
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    May 10, 2012
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE SUPPLIER PERFORMED THIS EVALUATION. DURING EVALUATION THE FOLLOWING OBSERVATIONS WERE NOTED: THE MANUFACTURING FACILITY HAS CONTROLS TO PREVENT THE INTRODUCTION OF FOREIGN MATTER ONTO PRODUCT. PERSONNEL WEAR HEAD-COVERS, GOWNS, AND SHOE-COVERS - NO DISCREPANCIES FOUND. CLEANING SCHEDULES ARE MAINTAINED FOR GOWNING AREAS AND PRODUCTION ROOMS - SCHEDULES MAINTAINED AS REQUIRED. NO EVIDENCE OF IN-PROCESS NONCONFORMITIES FOR THIS ISSUE. IN REVIEW OF THE AREA AND PROCESS USED TO INSPECT AND PACKAGE THE 43-1030, WE COULD NOT FIND ANY AREAS OF CONCERN THAT COULD HAVE PRODUCED THIS NONCONFORMITY. IN ADDITION, (B)(4) CONDUCTS 100% INSPECTION OF PRODUCT DURING THE POUCHING PROCESS AND AGAIN AFTER THE POUCHES ARE SEALED. SUBSEQUENTLY, THE SUPPLIER PERFORMS INSPECTIONS ON A SAMPLE OF EACH LOT OF PRODUCT UPON RECEIPT IN THE NEW LONDON FACILITY. SUPPLIER HAS MADE ALL PERTINENT PERSONNEL AWARE OF THIS ISSUE AND SHALL BE DILIGENT IN EFFORTS TO PREVENT ANY RECURRENCE. NOTE THAT AT THE PRESENT DATE, THIS IS THE FIRST COMPLAINT REPORTED FOR THIS LOT # 11J2047, FOR THIS TYPE OF ISSUE, AND IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    FOREIGN MATTER WAS NOTED IN THE STERILE PACKAGE BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DELAY IN SURGERY WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288851 CODMAN SURGICAL MARKER SKIN MARKER FZZ CODMAN & SHURTLEFF 11J2047-1011

    Patients

    Seq Age Sex Outcome Treatment
    1