BEUDAMED
    FDA Adverse Event Injury Summary report: N

    401 DENTAL NDL 27LG

    MDR report key: 4131354 · Received October 1, 2014

    Report

    Report Number
    1017768-2014-00025
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 022148 INDICATES THAT UNITS WERE PRODUCED ON (B)(6) 2010. THERE WAS ONE (1) RELATED ISSUE FOR DAMAGED HUB FOUND IN SAMPLES VISUALLY INSPECTED AND PHYSICALLY INSPECTED. THE PROCESS CORRECTION LOG FOR LOT 022148 WAS REVIEWED AND THERE WAS A CORRECTION OF CHECKED HUBS DOCUMENTED FOR THE ISSUE. ALTHOUGH ONE ISSUE WAS FOUND, BASED ON SAMPLING, THE LOT MET THE ACCEPTABLE QUALITY LEVEL (AQL) PER PROCEDURE. A REVIEW OF MAINTENANCE RECORDS (BOTH CORRECTIVE AND PREVENTIVE) AND CALIBRATION RECORDS WAS CONDUCTED AND THERE WERE NO ISSUES FOUND. ALL SCHEDULED MAINTENANCE AND CALIBRATION ACTIVITIES WERE COMPLETED. THERE WAS NO RELATED PROCESS OR MATERIAL CHANGES RELATED TO THIS TYPE OF ISSUE FOR THIS PRODUCT. A REVIEW OF THE PROCESS MONITORING DATA WAS CONDUCTED AND THERE WERE NO ISSUES WITH THE SCRAP DATA. A REVIEW OF THE MACHINE SETUP AND IN-PROCESS CHECKS WAS CONDUCTED AND THERE WERE NO ISSUES IDENTIFIED. THE VALIDATIONS ARE CURRENT AND IT IS RUNNING WITHIN VALIDATED PARAMETERS. ALL RECORDS IN COLD HEADING WERE REVIEWED DURING THE PRODUCTION AND PROCESSING TIME PERIOD AND ONE RECORD FOR WASHER PARAMETER VERIFICATION (COLD HEADING) WAS FOUND TO HAVE ISSUES. THE TEMPERATURE FOR THE WASH AND RINSE TANKS HAD BEEN DOCUMENTED OUTSIDE OF THE SPECIFICATION, THE DRYER HAD A SET POINT OF 210F, BUT VALUES WERE RECORDED FROM 86F TO 315F, AND THE PERCENT CONCENTRATION OF SOAP CONCENTRATION IN THE RINSE TANK WAS DOCUMENTED INCORRECTLY. WHEN THE PARAMETERS ARE FOUND OUTSIDE OF VALIDATED PARAMETERS, THE SETUP, SUPERVISOR, AND QA ARE TO BE NOTIFIED AND DOCUMENTED. ACTION TAKEN AND VERIFICATION MUST BE DOCUMENTED, BUT WAS NOT DONE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    THERE WAS ONE (1) USED SAMPLE RETURNED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED USING A 7X EYE LOOP AND THE VERTEX VISION SYSTEM. THERE IS YELLOWISH- AND GREENISH-WHITE POWDERY SUBSTANCE ON THE SURFACES OF THE ALUMINUM HUB. THERE IS ALSO THE PRESENCE OF CORROSION ON THE HUB, PARTICULARLY WHERE THE POWDERY SUBSTANCE IS LOCATED. THE SAMPLE WAS SUBMITTED TO THE ANALYTICAL LAB FOR FOREIGN MATERIAL IDENTIFICATION. USING THE SCANNING ELECTRON MICROSCOPE (SEM), THE LAB DETERMINED THAT THE RESIDUE HAD ELEVATED LEVELS OF OXYGEN THAT ARE CONSISTENT WITH AN OXIDATION OF THE METAL. THE ISSUE REPORTED BY THE CUSTOMER IS CONFIRMED. THE MOST-LIKELY ROOT CAUSE IS IMPROPER DRYING DURING PROCESSING IN COLD HEADING. THE ALUMINUM HUB IS DIPPED IN POT ASH, SULFURIC ACID, AND NITRIC ACID WITH WASHES/RINSES THROUGHOUT AND AT THE END PRIOR TO SPINNING (DRYING). THIS PROCESS IS TIMED. IF THE TIMING IS OFF OR THE HUBS ARE NOT COMPLETELY DRIED, THE RESIDUE FROM PROCESSING WILL CORRODE THE HUB. PRIOR TO A LOT'S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, SAMPLES ARE VISUALLY EXAMINED FOR PARTICULATES AND EXTRANEOUS MATTER ON OUTSIDE OF HUB AND CANNULA. THE LOT MET ALL ACCEPTANCE REQUIREMENTS AT THE TIME OF RELEASE. THE IN-HOUSE COLD HEADING OPERATION HAS BEEN STOPPED. SINCE (B)(6) 2012, THE COLD HEADING PROCESS HAS BEEN PERFORMED BY A SUPPLIER. IN-HOUSE EXAMINATION FOR ISSUES TO THE SUPPLIED HUBS IS STILL PERFORMED IN-HOUSE AT THE ASSEMBLY LEVEL. THE SUPPLIER PERFORMS A FINAL PRODUCT INSPECTION AT DOUBLE OUR AQL SAMPLING IN INCOMING INSPECTION. FOR EACH LOT, THE SUPPLIER CHECKS FOR CORROSION - CHEMICAL RESIDUE, STAINS, AND FOREIGN MATTER (FLUID PATH AND NON-FLUID PATH). ALSO, AFTER PROCESSING, THE PARTS ARE VISUALLY INSPECTED FOR CLEANLINESS AND/OR DRYNESS. FOR PARTS, WHICH APPEAR OILY, CONDUCTIVITY IS CHECKED TO ENSURE PROPER SOAP LEVEL. IF CONDUCTIVITY IS LOW, ADDITIONAL SOAP IS ADDED UNTIL CONDUCTIVITY REACHES SPECIFIED PARAMETERS. SOAP TYPES ARE NOT TO BE MIXED AND CLEANING PROCESS IS REPEATED. IF PARTS SHOULD BE DRY, BUT APPEAR WET, THE DRY CYCLE IS REPEATED. AS A CORRECTION FOR RECORD DOCUMENTATION ISSUES, REVIEW/APPROVAL WAS ADDED TO ALL DEVICE HISTORY AND PROCESS CONTROL RECORDS. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR ADDITIONAL CORRECTIVE ACTIONS. THE PRODUCTION DEPARTMENT WILL BE NOTIFIED OF THIS INCIDENT WITH A COPY OF THIS COMPLAINT RESPONSE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DENTAL NEEDLE. THE CUSTOMER REPORTS THAT THEY HAD TROUBLE GIVING A PATIENT AN INJECTION DURING A DENTAL PROCEDURE. THE CUSTOMER STATES THAT THEY THEN NOTICED CORROSION ON THE HUB WHICH WENT DOWN INTO THE NEEDLE. THE CUSTOMER REPORTS THEY DID A BASELINE FOR BBP (HEP B, HEP C AND HIV) AND TETANUS BOOSTER IF INDICATED BY HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611206 401 DENTAL NDL 27LG DENTAL NEEDLE DZM COVIDIEN 8881401056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other