BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATNAA ROUND FERRULE NDL

    MDR report key: 8113163 · Received November 28, 2018

    Report

    Report Number
    1017768-2018-00525
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    September 25, 2018
    Report Date
    December 12, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED POSSIBLE LOT NUMBERS 800865 AND 805037. THE DEVICE HISTORY RECORDS WERE REVIEWED AND INDICATED THAT THE PRODUCTS WERE RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. A REVIEW OF MAINTENANCE RECORDS (BOTH CORRECTIVE AND PREVENTIVE) AND CALIBRATION RECORDS WERE REVIEWED AND THERE WERE NO ISSUES. ALL SCHEDULED MAINTENANCE AND CALIBRATION ACTIVITIES WERE COMPLETED. THERE WERE NO RELATED PROCESS OR MATERIAL CHANGES RELATED TO THE REPORTED CONDITION FOR THIS PRODUCT. PROCESS MONITORING DATA FOR THE LOTS WAS REVIEWED AND THERE WERE NO ISSUES. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND THERE WERE NO ISSUES. THE JARS USED TO PACK THE PRODUCT WERE REVIEWED AND NO PARTICULATE OR FLASH WAS SEEN. SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION; HOWEVER, THERE WAS ONE PHOTO RETURNED WITH THIS COMPLAINT. A REVIEW OF THE PHOTO AND LAB REPORT WERE COMPLETED. BASED ON THE PHOTO AND LAB REPORT THE PARTICULATE APPEARS TO HAVE BEEN GENERATED FROM THE PLASTIC JAR. THE REPORTED CONDITION IS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE PARTICULATE IS THAT IT CAME FROM THE TOP OF THE JAR. 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, PRODUCT IS CHECKED FOR FOREIGN MATERIAL DURING THE PRODUCTION AND PACKAGING PROCESSES. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. A NOTE WAS ADDED TO THE FORMULA SHEET TO CHECK THE JAR FOR CONTAMINATION AND FLASH. A NOTE TO THE FORMULA SHEET TO CHECK THE JAR FOR CONTAMINATION AND FLASH. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR ADDITIONAL CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IS AN OEM UNSTERILE CANNULA. AFTER FURTHER REVIEW IT WAS DETERMINED THAT THIS REPORT WAS SUBMITTED IN ERROR AS THE INCIDENT DOES NOT MEET THE MDR REGULATION REQUIREMENTS OF A REPORTABLE EVENT. NO ADDITIONAL FOLLOW UPS OR INVESTIGATION RESULTS WILL BE SENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS DURING AN INSPECTOR OBSERVED A PIECE OF CLEAR PARTICULATE INSIDE THE NEEDLE BOWL. POSSIBLE LOT NUMBERS 800865 AND 805037. SINCE THE CUSTOMER COMBINES COMPONENT LOTS, THEY ARE UNABLE TO SPECIFY THE SOURCE LOT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952911 ATNAA ROUND FERRULE NDL NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 7070005 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1