BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 G SHORT PLASTIC

    MDR report key: 6076517 · Received November 3, 2016

    Report

    Report Number
    1017768-2016-00100
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Report Date
    October 6, 2016
    Manufacturer
    COVIDIEN
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE REPORTED CONDITION WAS PERFORMED. THE REVIEW OF DEVICE HISTORY RECORD (DHR) INDICATES THAT NO ISSUES WERE FOUND FOR THE REPORTED LOT. THE REVIEW OF MAINTENANCE AND CALIBRATION RECORDS, MACHINE SET UP, PROCESS MONITORING DATA DETECTED NO ISSUES. ALL SCHEDULED MAINTENANCE AND CALIBRATION ACTIVITIES WERE COMPLETED ON TIME. THERE WERE NO PROCESS OR MATERIAL CHANGES THAT HAVE OCCURRED FOR THE REPORTED CONDITION. THE CURRENT STATE OF THE MACHINE WAS FOUND TO BE OPERATING NORMALLY. THE EXACT ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED WITHOUT AN ACTUAL SAMPLE. WITH THE LITTLE EVIDENCE AVAILABLE, THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED AS WELL. PRIOR TO A LOT 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, VISUAL INSPECTION IS PERFORMED FOR CORRECT ASSEMBLY AND PULL TESTED FOR CANNULA TO HUB SECURITY. THE LOT RELEASED MET ALL DEFINED ACCEPTANCE REQUIREMENTS. NO CORRECTIVE AND PREVENTIVE ACTIONS ARE DEEMED NECESSARY NOW. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS. THE PRODUCTION DEPARTMENT WILL BE NOTIFIED ABOUT INCIDENT WITH A COPY OF THIS COMPLAINT RESPONSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A DENTAL NEEDLE. THE CUSTOMER STATES THE NEEDLES ARE DEFECTIVE BECAUSE THE METAL PARTS SEPARATE FROM THE TIPS, AND FALL TO THE GROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727817 30 G SHORT PLASTIC DENTAL NEEDLE DZM COVIDIEN 8881400074 611628

    Patients

    Seq Age Sex Outcome Treatment
    1