BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30G DENTAL NDL

    MDR report key: 4892134 · Received July 6, 2015

    Report

    Report Number
    1017768-2015-00019
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Report Date
    February 4, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DZM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SERIOUS INJURY INSTEAD OF MALFUNCTION

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. THERE WERE NO SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT AVAILABLE FOR EVALUATION, A ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF THIS REPORTED ISSUE. IF SAMPLES ARE RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE RE-OPENED AND THE INVESTIGATION CONTINUED. THE MOST LIKELY ROOT CAUSE CAN BE DUE TO THE METHOD OF INJECTION BY INSERTING THE CANNULA TO THE HUB AND BENDING. 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, ALL LOTS OF NEEDLE TUBING ARE STATISTICALLY SAMPLED AND TESTED FOR BREAKAGE PER CERTIFICATION STANDARD. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. THIS INFORMATION WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS. THE PRODUCTION DEPARTMENT WILL BE NOTIFIED OF THIS REPORTED ISSUE.

    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 THE DENTIST WAS INJECTING A PATIENT AND A PART OF THE NEEDLE BROKE INSIDE THE PATIENT'S GUM. THE PATIENT WENT TO ANOTHER CLINIC TO HAVE THE REMAINING PART REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437438 30G DENTAL NDL DENTAL NEEDLE DZM COVIDIEN 8881401072

    Patients

    Seq Age Sex Outcome Treatment
    1 Other